Published online March 26, 2007
PEDIATRICS Vol. 119 No. 4 April 2007, pp. e947-e957 (doi:10.1542/peds.2006-1717)
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ARTICLE

Follow-up Care for Infants With Chronic Lung Disease: A Randomized Comparison of Community- and Center-Based Models

T. Michael O'Shea, MD, MPHa,b, Savithri Nageswaran, MBBS, MPHa,b, Debbie C. Hiatt, BSN, RNa, Claudine Legault, PhDb, Mary Lou Moore, PhD, RNc, Michelle Naughton, PhD, MPHb, Donald J. Goldstein, PhDa and Robert G. Dillard, MDa

Departments of a Pediatrics
b Social Sciences and Health Policy
c Obstetrics and Gynecology, Wake Forest University School of Medicine, Winston-Salem, North Carolina


   ABSTRACT
TOP
 ABSTRACT
METHODS
 RESULTS
 DISCUSSION
 CONCLUSIONS
 REFERENCES
 
OBJECTIVES. Premature infants with chronic lung disease benefit from comprehensive care, which typically is based in tertiary medical centers. When such centers are not easily accessible, alternative models of care are needed. The purpose of this work was to compare community-based follow-up, provided via telephone contacts, to traditional center-based follow-up of premature infants with chronic lung disease.

PATIENTS AND METHODS. After discharge from neonatal intensive care, 150 premature infants with chronic lung disease were randomly assigned to either community-based (n = 75) or center-based (n = 75) follow-up. In community-based follow-up, a nurse specialist maintained telephone contact with the infant's primary caregiver and health care providers. Center-based follow-up consisted of visits to a medical center–based multidisciplinary clinic staffed by a neonatologist, a nurse specialist, and a social worker. The outcomes of interest were Bayley Scales of Infant Development mental developmental index and psychomotor developmental index, Vineland Adaptive Behavioral Composite, and growth delay (weight for length <5th percentile) at 1-year adjusted age and respiratory rehospitalizations through 1-year adjusted age.

RESULTS. In each randomization group, 73 infants survived, and 69 were evaluated at 1-year adjusted age. The median mental development index (corrected for gestational age) was 90 for both groups. The median psychomotor developmental index was 82 for the center-based group and 81 for the community-based group. The median Vineland Adaptive Behavioral Composite was 100 and 102 for the center-based and community-based groups, respectively. In the center-based and community-based groups, respectively, the proportions with growth delay were 13% and 26%, and the proportions rehospitalized for respiratory illness were 33% and 29%.

CONCLUSIONS. Infants randomly assigned to community-based, as compared with those randomly assigned to center-based follow-up, had similar developmental and health outcomes. The former approach might be a preferred alternative for families in rural settings or families for whom access to a tertiary care medical center is difficult.

Key Words: bronchopulmonary dysplasia • chronic lung disease • prematurity • health services research • neonatal follow-up

Abbreviations: CLD—chronic lung disease • BSID—Bayley Scales of Infant Development-Second Edition • MDI—mental developmental index • PDI—psychomotor developmental index • OR—odds ratio • CI—confidence interval

The American Academy of Pediatrics recommends that children with special health care needs receive comprehensive and coordinated care.1 Such care, provided to very low birth weight infants, decreases the risk of serious illness requiring hospitalization in the first year of life after discharge from neonatal intensive care.2 Among very low birth weight infants, chronic lung disease (CLD) is the most prevalent chronic illness and underlies many of their special health care needs.3

Infants with CLD are prone to frequent respiratory illnesses, feeding difficulties,4 growth failure,5–7 and rehospitalization during infancy,4,8 and their families incur financial and psychosocial costs during and after their infants' neonatal intensive care.9,10 After resolution of severe pulmonary symptoms, children recovered from CLD are at increased risk for cognitive impairment,11,12 motor11 and language impairment,13–15 hearing loss,16 and poor academic performance.14

We and others have described models for providing special health services and support to children with CLD and their families after hospital discharge.17–20 Children with CLD who received multidisciplinary comprehensive care at a regional medical center, when compared with historical control subjects, had improved health and developmental outcomes.17 Although multidisciplinary care clinics seem to benefit children with special health care needs, such clinics may not be easily accessible to some families, for whom alternative models of care may be preferable.

On the basis of a model developed for providing prenatal support to mothers at high risk for preterm delivery,21 we developed an alternative to medical center–based follow-up of prematurely born infants with CLD. In this model, which we will refer to as community-based care, medical management was coordinated by a nurse specialist through frequent telephone contacts with the infants' primary caregiver. Here we report the primary results of a randomized comparison of community-based care with the more traditional model of multidisciplinary medical center–based care for prematurely born infants recovering from neonatal CLD. We hypothesized that the 2 models would lead to similar developmental and health outcomes during the first year of life.


   METHODS
TOP
 ABSTRACT
 METHODS
RESULTS
 DISCUSSION
 CONCLUSIONS
 REFERENCES
 
Study Design
The study was a randomized comparison in which participants were not blinded as to the intervention, but those who assessed the primary outcome were blinded. The study was approved by the Wake Forest University Health Sciences Institutional Review Board.

Study Participants
Study infants were born between March 1996 and April 1999; follow-up assessments were completed between June 1997 and August 2000. Infants who were eligible for the study were identified by weekly contact with 5 NICUs, which, at the time of the study, were the only sites providing neonatal intensive care in a 20-county region in northwest North Carolina. Infants were eligible if they were born before 33 weeks' gestational age, required supplemental oxygen at 36 weeks' postmenstrual age, and were discharged from the hospital after neonatal intensive care. Neonates who had a major congenital anomaly or a tracheostomy were excluded, as well as families in which the mother did not speak English (because the intervention depended on verbal communication with the nurse specialist) and families who lived >150 miles from our clinic (because such families typically are referred to regional neonatal centers closer to their homes). The nurse specialist (Ms Hiatt) visited the family in their home to establish a relationship before random assignment. Written informed consent to participate in the study was obtained from the parent of each randomly assigned infant.

Random Assignment
For each of the sites at which infants were recruited, a list of randomization assignments, in block sizes of 2 or 4, was prepared by a biostatistician (Dr Legault). These lists were kept in a sealed envelope in a locked drawer, and after each study participant arrived home from the NICU, a research assistant informed the nurse specialist (Ms Hiatt) of the randomization assignment. The nurse specialist then informed the family, primary care provider, and study neonatologists. Within 24 hours after random assignment, the principal investigator called each infant's primary care provider to inform him or her of the study and the infant's randomization assignment. Although data were collected from all members of multiple gestations, only 1 member was selected at random for inclusion during the analysis of data, because infants from a multiple gestation were not regarded as independent observations. The randomization process and the patient flow are described in Fig 1.


Figure 1
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  		FIGURE 1 Patient flow diagram.

 
Intervention
For the center-based group, the intervention team included the nurse specialist, a social worker, and 2 study neonatologists (Drs O'Shea and Dillard). The community-based group received direct contact only from the nurse specialist, although the nurse specialist involved the study neonatologists in specific circumstances, as described below.

If a family lacked telephone service when their infant was discharged, a telephone was installed at no cost to the family, within 1 week of the infant's discharge from the hospital. All of the families who participated in the study were reimbursed for the cost of local telephone service for the duration of the study. Families assigned to either intervention could contact the nurse specialist on a toll-free long-distance line; a voice mail system recorded messages when the telephone was not attended.

Community-Based Follow-up
The nurse specialist called the infants' primary caregiver twice weekly in the first month after discharge, weekly in months 2 through 4, and monthly thereafter until the infant attained 12 months' adjusted age. At each telephone contact, the nurse specialist used a questionnaire to inquire about the infant's health, community resources used by the infant, potential stressors and sources of support for the family, and the infant's medications and feedings. If she judged that the infant would benefit from a change in medical management, additional assessments (eg, pulse oximetry), or a subspecialty referral, she discussed the infant with 1 of the study neonatologists and then communicated recommendations to the family and the infant's primary care provider. The nurse specialist also coordinated care by communicating with home health nurses, public health nurses, early intervention specialists, physical therapists, and pediatric subspecialists. The primary care provider was contacted by the nurse specialist whenever she believed that a change in care was indicated.

Medical Center–Based Follow-up
For infants who were discharged from the hospital using supplemental oxygen, the nurse specialist made a home visit 1 to 2 weeks after discharge. During this visit, she obtained an interim medical history, performed a physical assessment including pulse oximetry, and reviewed discharge instructions regarding medications and durable medical equipment. If concerned about the infant, she consulted a study neonatologist and, if appropriate, recommended a change in the plan of care.

All of the infants in the center-based care group were seen in a multidisciplinary clinic for high-risk infants at Wake Forest University School of Medicine. Each visit included assessments by the social worker, nurse specialist, and a study neonatologist. The social worker assessed family stressors and resources; the nurse specialist obtained an interim medical history (feeding, respiratory status, medication use, illnesses, and health-services use) and anthropometric measurements; and the neonatologist performed a physical examination. Together, the 3 developed a plan of care, which the nurse specialist communicated to the family.

For all of the infants, the first clinic visit was scheduled for ~1 month after their discharge, and subsequent visits were scheduled at 4, 8, and 12 months' adjusted age. In addition, infants using supplemental oxygen were scheduled for visits every 1 to 2 months until they were no longer using supplemental oxygen, medications, or an apnea monitor and their growth rate was 15 to 30 g per day. After each clinic visit, a letter describing findings, impressions, and recommendations was sent to the primary care provider.

Care During Rehospitalizations
When an infant in the community-based follow-up group was rehospitalized, the study neonatologists were not involved in medical decisions during the hospitalization. When an infant randomly assigned to center-based care was rehospitalized at our medical center, the study neonatologist visited the infant in the hospital and served as a consultant to the attending physician.

Guidelines Used for Both Groups
A written protocol for management of CLD in neonates was developed on the basis of a National Institutes of Health consensus conference,22 and a copy was mailed to each infant's primary care provider. The general underlying principle was that infants' health was considered satisfactory if they gained 15 to 45 g of body weight per day and had no clinical features of the following: (1) gastroesophageal reflux (irritability and/or back arching during feeding or frequent regurgitation with poor weight gain); (2) excessive fluid retention (tachypnea, retractions, rales, excessive weight gain, liver enlargement, poor feeding, and oxygen saturations <92%); (3) obstructed airways (wheezing, prolonged expiratory phase of respirations, and liver edge felt >2 cm below the costal margin); or (4) delayed motor development (25% delay in the attainment of gross motor milestones).23 These signs and symptoms were assessed at each clinic visit of infants in the center-based follow-up group, and on the basis of the findings, the care plan was developed. In the community-based group, symptoms of gastroesophageal reflux and respiratory distress were based on parents' or guardians' report, as ascertained by the nurse specialist during telephone contacts; and data about oxygen saturations were collected each month by home health respiratory therapists.

While at home, infants for whom supplemental oxygen was prescribed received oxygen by nasal cannula, as 100% oxygen from H cylinders; portable D or E cylinders were used outside the home. Before discharge from the hospital, a respiratory therapist met with families and instructed caregivers on the use of oxygen and cardiorespiratory monitors. Respiratory therapists visited the infants' homes every 4 to 6 weeks to ensure appropriate functioning of the equipment. Pulse oximetry was performed at least monthly on all of the infants who were using supplemental oxygen (for the center-based care group, within our multidisciplinary clinic; for the community-based follow-up group, by home health respiratory therapists). According to the manufacturer's specifications, the pulse oximeter used in our clinic had a time-averaging interval of 4 to 7 seconds and was accurate to within 3%. Pulse oximetry was performed at rest, during an entire feeding, and for ~10 minutes after a feeding. If the oxygen saturations were consistently above 95%, the oxygen flow rate was decreased by 0.1 L/min, and pulse oximetry was repeated. If the saturations remained consistently >92%, the flow rate was maintained at this new (lower) level until the next clinic visit. Infants whose oxygen requirements increased over consecutive visits to the clinic were referred to a pediatric pulmonologist for consultation.

A cardiorespiratory monitor was prescribed for infants who used supplemental oxygen or had persistent apnea at the time of discharge from the hospital. Typically, the monitor was discontinued within 1 to 2 months after the infant was weaned to room air, except when the parent requested that the monitor be continued beyond that point.

For all of the infants, 100.42 J (24 cal)/oz of formula or fortified human milk was prescribed until the infant had weaned to room air. The adequacy of nutrition was assessed by computing the average daily weight gain between clinic or telephone patient encounters. If the average weight gain was >15 g per day, no changes were made in the infant's nutrition. If the average weight gain was <15 g per day, a plan was developed to address the presumed cause, such as hypoxemia or inadequate caloric intake.

Most infants who required supplemental oxygen at discharge were treated with chlorothiazide and spironolactone. Serum potassium and sodium had been assessed during the hospitalization, and hypokalemia and hyponatremia were not present in any of the infants at the time of discharge. Electrolytes were not monitored routinely after discharge, except in the small number of infants who were treated with furosemide. Inhaled albuterol and corticosteroids were prescribed for infants with wheezing. Gastroesophageal reflux was treated with cisapride or metoclopramide, plus ranitidine. Monthly immunoprophylaxis against respiratory syncytial virus was prescribed for all of the subjects. At the discretion of the attending neonatologists, postdischarge private duty nursing was prescribed before discharge (and randomization).

Measurements
Prerandomization Measures
A research assistant collected baseline data (eg, gestational age and neonatal complications) from medical charts. Information about the family demographics, stressors, resources, and rehospitalizations were collected by questionnaires completed by the mother or primary caregiver before random assignment.

Gestational age was based on the date of the mother's last menstrual period unless this was not available, in which case an obstetrician's estimate was used; when no prenatal estimate was available, gestational age was based on assessment of the neonate.24 "Small for gestational age" was defined as a body weight less than the 10th percentile for gestational age and gender.25 The radiologist's reports on cranial ultrasound were abstracted from medical charts. If the results of the cranial ultrasound were reported as normal by the radiologist, the ultrasound was classified as normal. Reports of abnormal cranial ultrasounds were reviewed by 1 of the study neonatologists (not blinded to treatment assignments) and classified as described by Stewart et al.26 Posthemorrhagic hydrocephalus, persistent ventricular dilatation, and periventricular echolucency were considered to be major abnormalities. The severity of lung disease was classified by a pediatric radiologist, using the severity scale described by Weinstein et al (grades 1–6, with 6 being the most severe).27 To estimate the number and duration of telephone contacts in the 2 groups, the study nurse recorded the data about the number and duration of telephone contacts for the first 92 infants randomly assigned (45 in the center-based group and 47 in the community-based group).

Outcomes Assessed at 1-Year Adjusted Age
The primary outcome of interest was the Bayley Scales of Infant Development-Second Edition (BSID) mental developmental index (MDI), a widely used measure of early cognitive functioning.28,29 Secondary outcomes were BSID psychomotor developmental index (PDI), Vineland Adaptive Behavioral Composite, growth delay, neurodevelopmental impairments, and rehospitalizations through 1-year adjusted age.

All of the children were evaluated at 1-year adjusted age at the Wake Forest University Development Evaluation Clinic. For most participants, this was ~12 months after random assignment, because most infants were discharged within a few weeks of the estimated date of confinement. Child psychologists or psychology graduate students supervised by a child psychologist, who were not aware of the child's intervention group or medical history, administered the BSID-MDI, PDI, and Vineland Adaptive Behavioral Scales. After the testing was completed, the psychologist was informed of the infant's gestational age at birth so that the BSID scores could be corrected for the degree of prematurity. When the raw score yielded a MDI or PDI score <50, we derived extrapolated scores as described by Robinson and Mervis.30 The Vineland Adaptive Behavior Scales are a parent-reported measure of child adaptive development, which yield an adaptive behavior composite.31

Anthropometric measurements were performed by the nurse specialist or 1 of the neonatologists using a pediatric scale for weight, a length board for length, and a tape measure for head circumference. Growth delay was defined as weight for length less than the fifth percentile at 1-year adjusted age.32 On the basis of the neonatologist's neurologic examination, infants with hypertonia and hyperreflexia in ≥1 extremity, accompanied by delayed motor milestones, were classified as having definite cerebral palsy. Infants were classified as having suspect cerebral palsy if they had hyperreflexia or hypertonia but were not delayed in attaining motor milestones.23 A research assistant, who was not aware of intervention group assignments, reviewed each infant's clinic chart to collect data about the presence of the following: hearing impairment (for which a hearing aid had been prescribed), blindness (diagnosed by a pediatric ophthalmologist), and seizure disorder (for which anticonvulsant agents had been prescribed). Neurodevelopmental impairment was defined as the presence of any 1 of the following: cerebral palsy, blindness, need for hearing aid, MDI of <70, or PDI of <70.

A research assistant reviewed the discharge summary from each rehospitalization and recorded the reason for the hospitalization. The principal investigator, without knowledge of the infant's identity, categorized the hospitalizations as follows: respiratory syncytial virus-related respiratory illness, respiratory illness without documentation of respiratory syncytial virus infection, elective surgery, or other.

Statistical Analysis
Descriptive statistics were obtained for prerandomization characteristics and outcomes. For comparisons between 2 groups for the primary outcome and for secondary outcomes measured as continuous variables, the Wilcoxon rank sum test was used. Associations between intervention group and dichotomous outcomes were expressed as odds ratios (ORs) and exact 95% confidence intervals (CIs). A P < .05 was considered statistically significant. Analysis was by intention to treat. Assuming a rate of sample attrition of 10% and an SD of 15 (the SD in the Bayley Scales standardization sample), 75 infants would provide 80% statistical power to detect a group difference of 0.5 SD (7.5 Bayley points) at the 5% 2-sided level of significance. In a previous study of infants with CLD, we had observed an SD of 23, and if this degree of variation is assumed, the minimal difference detectable at 80% statistical power would be 10.5. We used SAS 8.2 (SAS Institute, Cary, NC) and STATXACT (Cytel Software Corporation, Cambridge, MA) for statistical analysis.


   RESULTS
TOP
 ABSTRACT
 METHODS
 RESULTS
DISCUSSION
 CONCLUSIONS
 REFERENCES
 
Study Participants
Of 185 consecutive infants identified with CLD, 164 infants were eligible for the study, and the parents of 150 (92% of those eligible) agreed to participate. Seventy-five children each were randomly assigned to the community- and center-based groups (Fig 1). There was no crossover from 1 intervention arm to the other. The center-based group received or initiated a median of 16 calls (5th and 95th percentiles: 2 and 53), as compared with a median of 27 calls (5th and 95th percentiles: 3 and 73) in the community-based group (P = .02). The median total duration of calls was 68 (5th and 95th percentiles: 2 and 414) minutes for the center-based group and 212 (5th and 95th percentiles: 31 and 732) minutes for the community-based group (P < .001).

Prerandomization Attributes
Of the entire sample, nearly one third of mothers were black, one half were not married, and approximately one half were eligible for Medicaid. The median birth weight of study infants was 830 g, and the median gestational age was 26 weeks. At the time of discharge from the NICU, more than one half of the infants were using supplemental oxygen, and three quarters were using a cardiorespiratory monitor. Postdischarge private duty nursing was prescribed for 2 infants before discharge (and random assignment); both were randomly assigned to community-based care. Maternal and sociodemographic attributes before random assignment are described in Table 1. As shown in Table 2, infant attributes before random assignment were similar for the 2 intervention groups.


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  		TABLE 1 Maternal and Sociodemographic Characteristics Before Randomization

 

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  		TABLE 2 Clinical Characteristics of Infants Before Random Assignment

 
Outcomes
In the center-based group, 2 children died suddenly at home. One death was classified as because of sudden infant death syndrome and the other because of right ventricular failure secondary to pulmonary hypertension. In the community-based group, 1 infant died at home of presumed sudden infant death syndrome, and 1 infant died of cardiopulmonary failure after being readmitted to the hospital. Three of the infants who died were using supplemental oxygen when they died; in none of these infants was the oxygen flow weaned after discharge from neonatal intensive care. Of the 146 survivors, 4 in each group did not return for the 12-month follow-up visit. We obtained information about the developmental outcome of 7 of these children from local sources, including development evaluation centers (3 children), a local physician (1 child), and parents (3 children). Four were thought to have abnormal development and 3 to have possibly abnormal development. The 12 infants who died or did not return for evaluation at 12 months' adjusted age, as compared with those evaluated, were similar with respect to birth weight, gestational age, gender, race, and the proportion discharged using supplemental oxygen.

The median age at follow-up, adjusted for gestational age, was 12.3 months (5th and 95th percentile was 11.7 and 14.7 months, respectively). Outcomes for infants whom we evaluated at 12 months' adjusted age are shown in Table 3. No difference was found in the group medians for the primary outcome of interest (the BSID-MDI), nor were differences found for the other developmental or health outcomes. The difference (community-center) in mean MDI was 3.4 (95% CI: –2.7 to 9.5), and the difference in mean PDI was –0.1 (95% CI: –6.7 to 6.9). Weight for length less than the fifth percentile was found more frequently among infants randomly assigned to community-based follow-up, although the difference was not statistically significant (ORcommunity/center: 2.31; 95% CI: 0.96 to 5.60). Similar proportions of the 2 groups were rehospitalized for respiratory illness (ORcommunity/center: 0.82; 95% CI: 0.40 to 1.68).


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  		TABLE 3 Developmental and Health Outcomes of Children With CLD at 1 Year

 

   DISCUSSION
TOP
 ABSTRACT
 METHODS
 RESULTS
 DISCUSSION
CONCLUSIONS
 REFERENCES
 
The results of this clinical trial indicate that, for prematurely born infants with CLD, community-based follow-up, coordinated by a nurse specialist via frequent telephone contacts, is a safe alternative to the prevailing model of health services for such infants, that is, a multidisciplinary medical-center based follow-up. Our study suggests that telephone follow-up, like multidisciplinary clinics, can be used to facilitate compliance with medical recommendations, such as those developed for CLD,22 and to provide social and emotional support for the parents, referrals to subspecialty and early intervention services, developmental surveillance, and care coordination. In separate reports, we will compare the 2 approaches to follow-up in terms of costs, processes of care, satisfaction with the care provided, and psychosocial outcomes for families.

Children with chronic medical conditions like diabetes and asthma have improved clinical outcomes from comprehensive and coordinated care.33–36 Such care decreases life-threatening illnesses and hospitalizations of high-risk infants.2 In addition, coordinated care improves parents' satisfaction with health care and decreases health care use of children with special health care needs.37,38 However, access to such coordinated, comprehensive care may not be readily available, especially in rural areas where resources are limited. Frequent telephone contact with a health care professional is one method by which comprehensive care can be provided to children with chronic conditions in rural areas, where access to a complex level of care is limited.

Telephone intervention has been successfully used for the management of chronic illnesses in adults.39,40 In children, telephone management used in diabetes care did not significantly improve glycemic control, but it increased knowledge about diabetes care and adherence to care.41,42 In a randomized trial in low-income pregnant women, frequent telephone calls from a registered nurse were not associated with a statistically significant difference in the rate of low birth weight births; but in the subgroup of study participants who were black and >19 years of age, a statistically significant difference was found (relative risk: 0.56; 95% CI: 0.38 to 0.84; P = .004).21 We are aware of no published descriptions of longitudinal telephone follow-up for infants with special health care needs.

Community-based follow-up was associated with a twofold greater risk of growth delay, which, although not a statistically significant effect, does raise the possibility that some aspect community-based follow-up care was inferior to center-based care. Observational studies suggest that discontinuance of supplemental oxygen can result in a slowing of weight gain among infants with CLD,43 particularly those who experience oxygen saturations <92% during sleep.44 The oxygen saturation target that was used in our study is very close to that used in the largest randomized trial of home oxygen therapy reported to date.45 However, if pulse oximetry in our clinic, as compared with pulse oximetry in the home, more accurately reflected an infant's minimum saturations during sleep, then the group difference in growth during the first year might be attributable to more optimal oxygen saturations in the center-based follow-up group. Of note, however, is that the weaning of this group of infants from supplemental oxygen was not slower.

In addition to the slowing of weight gain, other adverse outcomes that are possibly related to hypoxemia during sleep include sudden infant death syndrome, the cause of death in 1 study participant in each group, and right ventricular heart failure, a factor in the other 2 deaths.46 The flow of supplemental oxygen was not weaned for any of the infants who died, but because we did not measure oxygen saturations continuously, it is plausible that these infants might have benefited from even higher oxygen flows than were used. Regarding the assessment of oxygen saturations in infants with CLD, a panel of experts suggested that "multiple determinations [be] made in various states including rest, sleep, feeding, and high activity, and in various positions."47 Although this panel described continuous oxygen saturation monitoring at home as "helpful," no explicit recommendation was made regarding its application.

Despite numerous advances in neonatology during the last 5 decades and remarkably improved rates of survival,48 the prevalence of CLD has not decreased.49 The impact of CLD increases with increasing severity, and patients who continue to require supplemental oxygen at 36 weeks' postmenstrual age, as was true of the infants whom we studied, are at highest risk for adverse health and developmental outcomes during early childhood.50 The rates of mortality, rehospitalization, and neurodevelopmental impairment described here are similar to those reported by Ehrenkranz et al,50 who studied 2269 extremely low birth weight infants with moderate or severe bronchopulmonary dysplasia (ie, requirement for supplemental oxygen at 36 weeks' postmenstrual age). In that study, 3% of infants died after discharge from neonatal intensive care (2.7% in the current study), 36.6% were readmitted for respiratory disease (31% in the current study), and 50.8% were found to have neurodevelopmental impairment, that is, MDI or PDI of <70, cerebral palsy, blindness, or deafness, at 18 months' adjusted age (35% at 12 months' adjusted age, in the current study).

We should acknowledge that the benefit of several interventions used in this study to infants with resolving CLD and no longer requiring mechanical ventilation, such as diuretics, medications for gastroesophageal reflux, and bronchodilators, is not supported by randomized clinical trials. Although at the time that this trial was conducted many experts recommended treatment of infants with CLD with diuretics,51–53 the routine use of diuretics for infants with CLD is discouraged in recent reviews.54 Whereas there is agreement about the benefit of supplemental oxygen to infants with CLD, controversy still exists regarding the oxygen saturations that should be targeted.46,55 More research is needed related to the care of infants with CLD after discharge from neonatal intensive care.47

Limitations of our study should be noted. First, our failure to detect certain group differences might be because of limited statistical power. For example, although the twofold group difference in the rate of growth delay was not statistically significant, posthoc power calculations indicate that our study had only 50% power to detect a twofold increase in the frequency of growth delay. Second, only 1 intervention team was used, which limits the generalizability of our conclusions. Furthermore, because we included only English-speaking families in the study, we cannot generalize our findings to non–English-speaking families. The study team and other health care providers were not blinded to the randomization assignment, so cointerventions might have been differentially applied, leading to bias. Finally, neurodevelopmental status was evaluated at 1-year adjusted age, when assessments of early cognitive functioning and neurologic status (eg, presence of cerebral palsy) are only moderately predictive of status later in childhood.56–59


   CONCLUSIONS
TOP
 ABSTRACT
 METHODS
 RESULTS
 DISCUSSION
 CONCLUSIONS
REFERENCES
 
This study indicates that telephone follow-up is a safe alternative to multidisciplinary clinic follow-up for ≥1 group of infants with complex medical needs, that is, those with CLD. This approach might be the preferred option for families who live far from a tertiary medical center. To the extent that CLD is an appropriate paradigm for chronic illness during infancy, our findings could apply to infants with other complex medical conditions.


   ACKNOWLEDGMENTS
 
The Agency for Healthcare Research and Quality (grant R01 HS07928; principal investigator: Dr O'Shea) provided financial support for the design and conduct of the study and collection, management, and interpretation of the data. The assessment of the primary outcome was supported by the North Carolina Department of Health and Human Services.

We thank Sam T. Auringer, MD, who reviewed chest radiographs used to assess study participants' disease severity, and Karen Klein, MA, for providing editorial assistance.


   FOOTNOTES
 
Accepted Oct 10, 2006.

Address correspondence to T. Michael O'Shea, MD, MPH, Department of Pediatrics, Wake Forest University Health Sciences, Medical Center Boulevard, Winston-Salem, NC 27157. E-mail moshea{at}wfubmc.edu

Dr O'Shea had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

The authors have indicated they have no financial relationships relevant to this article to disclose.


   REFERENCES
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 ABSTRACT
 METHODS
 RESULTS
 DISCUSSION
 CONCLUSIONS
 REFERENCES
 

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