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PEDIATRICS Vol. 105 No. 1 January 2000, pp. 66-72
,,,
From the * Department of Clinical Science, Pediatrics, Umeå
University, Umeå, Sweden; Neonatal Programme, Department of Woman
and Child Health, Astrid Lindgren Children's Hospital, Karolinska
Institute, Stockholm, Sweden; and the § Departments of Pediatrics and
Psychology, University of Lund, Lund, Sweden.
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ABSTRACT |
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Abstract
Methods
Results
Discussion
References
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Background and Objective. Family-centered developmentally supportive care of very low birth weight infants, provided by the Newborn Individualized Developmental Care and Assessment Program (NIDCAP) has been reported to have positive medical and economic impacts. Our aim was to investigate its effect on need of ventilatory assistance, growth, and hospitalization in a Swedish setting.
Methods. Preterm infants born between September 1994 and April 1997 with a gestational age <32 weeks and with a need of ventilatory assistance at 24 hours were randomly assigned to either NIDCAP (n = 12) or conventional care (n = 13). The 2 groups were comparable (median [range]) with respect to birth weight (1083 [630-1411] vs 840[636-1939 g]), head circumference (24.0 [22.3-26.5] vs 24.0 [21.1-30.0 cm]), gestational age (27.6 [24.0-28.7] vs 26.1 [23.9-30.3] weeks), female/male ratio (3/9 vs 9/8) and Clinical Risk Index for Babies (4.0 [0-11] vs 6.0 [2-15]). The infants in the intervention group were cared for in a separate room by a group of specially trained nurses. Formal weekly observations of these infants starting within 3 days after birth and continuing until 36 weeks postconception were used to develop individualized care plans. These plans provided recommendations as to how care might be attuned to the current developmental stage of the infant and how the family might be supported and stimulated to participate in this care. The treatment of the 2 groups was in all other respects identical.
Results. The duration of mechanical ventilation (median [range] was 2.8 [0-36.7] days in the intervention group vs 4.8 [.1-29.8] days; not significant [NS]) among the controls and continuous positive airway pressure was applied for 26.1 (6.9-52.0) vs 43.9 (5.0-65.1) days. Supplementary oxygen was withdrawn at 33.0 (29.3-35.7) vs 38.1 (33.1-44.9) weeks of postconceptional age (PCA). The weight gain up to 35 weeks of PCA was 13.0 (6.7-21.0) vs 9.8 (6.8-16.6) g/day (NS). The head growth up to 35 weeks of PCA was .73 (.56-1.3) vs .63 (.56-.77) cm/week (NS). The age of the infant at discharge was 38.3 (36.1-57.7) vs 41.0 (36.9-48.4) weeks of PCA (NS).
Conclusions. NIDCAP does not seem to have detrimental effects on Swedish very low birth weight infants in comparison with conventional care. Indeed, NIDCAP might even be advantageous. Key words: infant, very low birth weight growth and development infant, low birth weight infant, newborn infant, premature growth and development infant, premature infant, premature, diseases nursing infant, premature, diseases prevention and control, intensive care units, neonatal standards intensive care units, neonatal utilization intensive care, neonatal methods intensive care, neonatal nursing methods, neonatal nursing standards, patient care planning standards, bronchopulmonary dysplasia/prevention and control/therapy, human.
The survival of very low birth weight infants (VLBW; <1500
g) has increased from 50%1 to >80%2,3 since the initiation of neonatal intensive care in the early 1970s. However, a concomitant decrease in morbidity has not yet been conclusively shown to have taken place.
Long-term pulmonary morbidity has been an issue of great concern ever
since Northway and associates4 first described bronchopulmonary dysplasia (BPD) in 1967. Nevertheless, its incidence seems to have remained unchanged at 25% to 30%, because of the increasing number of extremely low birth weight infants (<1000 g) who
survive.5,6
Neurodevelopmental outcome is another major issue for VLBW infants.
Follow-up studies have reported the incidence of disability to be 15%
to 25%,7-9 a figure that has also remained fairly
constant over time.7,10 In addition, as an increasing
number of survivors reach school age, more minor impairments cause
great concern. Difficulties with attention, behavior, visual-motor
integration, language performance, and academic skills seem to
demonstrate a prevalence of ~40%.11-15
Both animal and human studies have documented the manner in which the
sensory input influences the structure and function of the central
nervous system, as well as the behavior of the newborn.16-18 Infants born with a VLBW receive inadequate
stimulation. Treatment and care-giving procedures cause pain and
discomfort, making it difficult for VLBW infants to experience restful
and undisturbed periods of sleep. During a 24-hour observation period,
such infants have been reported to be handled on the average >200
times.19 Furthermore, the care-giving itself was found to
be associated with three fourths of all hypoxemic episodes in a group
of 15 preterm infants.20 Increased levels of stress
hormones have been observed to occur in association with routine
nursing procedures.21
Family-Centered Developmentally Supportive Care
The important role of the family in caring for VLBW infants has
also been emphasized and the concept of family-centered care has been
strongly advocated.22 Minde et al23 have
shown that neonatal illness may have a lasting negative effect on
parent-infant interactions.
Als24 has integrated findings from other scientific
disciplines with those from developmental psychology and formulated a
new idea of care-giving, which puts the focus on respect for the very
tiny human being. She developed a theoretical framework for
family-centered, developmentally supportive care, the so-called Synactive Theory, which describes the infant as an organism displaying 5 subsystems, ie, the autonomic-physiologic, motor, state
organizational, attentional-interactive, and self-regulatory systems.
These systems are described as interactive, with Als pointing out how
the functional state of 1 system profoundly influences the others.
Thus, the stability and efficient functioning of 1 of these systems
affects the functions of the other systems in a positive fashion. For example, helping an infant to calm down his/her movements results in
improved autonomic function, with improved respiration and saturation,
which in turn also promotes the infant's ability to interact socially
with the parent or caregiver. The 5 subsystems interact
synergistically.
Based on this theoretical framework, Als developed the program of
intervention known as the Newborn Individualized Developmental Care and
Assessment Program (NIDCAP). The major approach used in this program is
weekly, formalized, naturalistic observations of the infant before,
during, and after a care-giving procedure, eg, feeding, changes of
diaper, collection of a blood sample, repositioning, etc. Behavioral
and physiologic changes are monitored by 2-minute epochs. Subsequently
the observer evaluates the infant's current ability to organize and
modulate his/her 5 subsystems and notes the infant's signals of well
being and self-regulation, as well as signals of sensitivity and
stress. The infant's behavior, described as avoidance of or approach
toward stimuli, enables the observer to assess how the infant strives
to cope with his/her environment and continue his/her development.
These observations provide information concerning the infant's
strengths and weaknesses at the point of time in question. In addition,
information is obtained concerning how well the environment, the
caregivers, and family members are attuned to the current needs of the
infant.
Subsequently, the observer writes a report describing in detail the
behavior of the infant during the entire observation. This report is
then used to explain the behavior of the infant in guidance of the
parents and caregivers by illustrating complex interactions among the
infant's different subsystems. For a trained observer, this entire
procedure requires 3 to 4 hours.
Based on this procedure, recommendations with respect to care-giving
designed to support the individual infant's development are
formulated. Such recommendations may include details on how to:
The group of Als and others have reported substantial positive effects of NIDCAP with respect to both the short-term medical and behavioral outcomes (eg, less requirement for assisted ventilation, fewer intracranial hemorrhages, faster weight gain, shorter hospitalization, and better behavioral scores at the time of discharge,25-32 as well as improvements in parent-infant interactions33 and the child's development).25,27
During recent years, a rapidly growing interest in NIDCAP has been demonstrated by neonatal nurses in both North America and Sweden but the program has met more skepticism from physicians. Some neonatologists recommend general use of the method,34 whereas others are skeptical, criticizing published studies as being conducted with inappropriate methodology and before the general use of prenatal steroids and surfactant. Furthermore, the intervention is believed to be cumbersome and time-consuming and the results too good to be true.35-37
The aim of the present randomized controlled trial (RCT) was to examine the effects of NIDCAP in a Swedish setting. In this report on short-term results, our primary hypothesis was that there would be no impact on the requirement for assisted ventilation, growth, or the period of hospitalization. Other aspects of this study (eg, the impact of NIDCAP on physiologic variables, parental experience, the mother-infant relationship, and follow-up data) will be reported later.
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METHODS |
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Abstract
Methods
Results
Discussion
References
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The number of infants required for this study was estimated using a nomogram for a 2-sample comparison for a continuous variable relating a power of 80%, a significance level of .05 and the standardized differences estimated from the findings of the previous studies. An increased daily weight gain of 3 g, a decreased need of supplementary oxygen of 25 days, and a 2 weeks earlier discharge would yield to a sample size of 40, 56, and 48 infants, respectively.
This study was conducted at the tertiary neonatal intensive care unit of the Karolinska Hospital in Stockholm, Sweden. Recruitment began in September 1994. It proceeded much more slowly than expected, because of a drop in the birth rate and political decisions about health care (including downsizing). There was also an increasingly strong opinion among the nursing staff that NIDCAP should be implemented throughout the unit. Thus, after having studied only 25 infants, we decided to terminate this study in April 1997.
Inclusion criteria consisted of: 1) inborn, 2) singleton, 3) postconceptual age (PCA) of <32 weeks, 4) absence of severe malformation, 5) need of ventilatory support 24 hours after birth, at least in the form of continuous positive airway pressure (CPAP), 6) family residence in the geographical district of the hospital to ensure full hospital stays at the study hospital, and 7) Swedish language facility attributable to the design of the follow-up.
To assure the NIDCAP intervention onset at birth, the infants were randomized immediately using sealed envelopes in blocks of 4. Infants assigned to the intervention were admitted to a special room directly after delivery. Informed consent was obtained. This procedure resulted in the randomization of infants who did not fulfill all the criteria for selection 24 hours after birth, who were subsequently excluded from the study.
One of 3 preexisting nursing teams was assigned to the NIDCAP infants. This team had been specially trained and was additionally supported by 2 formally NIDCAP-certified nurses. The infants were received weekly formal NIDCAP observations, starting within 3 days after birth and continuing until 36 weeks of PCA. In all other respects, the treatment of the 2 groups was identical. The ethical committee of the hospital approved the study.
In all cases, gestational age was determined by ultrasound during early pregnancy. The severity of illness was analyzed using the Clinical Risk Index for Babies (CRIB),38 which is calculated from the birth weight and gestational age, as well as the levels of blood gases and fraction of the inspired oxygen during the first 12 hours.
CPAP treatment was administered to all infants demonstrating spontaneous respiration at birth. Surfactant installation and mechanical ventilation was initiated when respiratory efforts were deemed inadequate, when frequent apneas occurred, and/or when CPAP with 5 to 6 cm H2O and FIO2 >.4-.6 produced a PO2 <6 kPa, PCO2 >8.5 kPa, and/or pH <7.25. CPAP treatment was terminated at pressures of 2 cm H2O and FIO2 <.3. Transcutaneous oxygen saturation was maintained at 90% to 94%. The periods of mechanical ventilation and CPAP treatment were registered by the hour. In contrast, the use of supplementary oxygen, when supplied daily for >1 hour, was expressed in days.
BPD was assessed by chest radiograph at 36 weeks of PCA according to a modified version of the recommendations of Toce et al.39 Interstitial parenchymal changes, overall lung expansion, and focal emphysema were given scores from 0 to 2. The severity of BPD was classified from the total score as follows: mild, 1 to 3; moderate, 4 to 5; severe, 6. Subsequently, the infants were grouped in 2 categories: none-mild and moderate-severe.
Apneas were quantified from the charts. Sepsis was concluded to be present when a blood culture result was positive and/or antibiotic treatment was administrated for >6 days in response to clinical symptoms and elevated C-reactive protein. The endpoint for the measurement of growth parameters was set at 35 weeks of PCA to include subjects discharged early from the hospital.
All the infants were subjected to a cranial ultrasound examination within the first week after birth and weekly thereafter if clinically warranted. Intraventricular hemorrhage (IVH) was recorded according to Papile et al.40 Eye examinations were performed on all survivors after 32 weeks of PCA, following the guidelines of the International Committee for the Classification of Retinopathy of Prematurity.41
The continuous variables were compared statistically using the
Mann-Whitney U test. For categorical variables
2 with exact P values and Fisher's
exact test were used. An overall P value of <.05 was
obtained by sequential adjustment for multiple tests according to
Holm.42 The statistical analyses were performed employing
the SPSS Version 8.0 (SPSS Inc, Chicago, IL).
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RESULTS |
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Abstract
Methods
Results
Discussion
References
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Between September 1994 and April 1997, all 41 prospective subjects
for inclusion in this study were identified, ie, ~20% of all infants
admitted to the unit with a gestational age <32 weeks. Of these
infants, 31 proved to be eligible for inclusion 24 hours after birth,
the time for definitive enrollment. Twelve had been chosen randomly for
the NIDCAP intervention and 19 for conventional care. The parents of 6 infants, all assigned to the control group, decided not to participate
in the study (birth weight: 888 [199 g] mean [standard deviation];
gestational age: 26.7 [1.4] weeks; CRIB: 3.8 [3.4]; female/male:
3/3; SGA: 2/6). The investigation of the physiologic data (stress
hormones in saliva, urine, and electroencephalogram
not reported in
this article) could possibly have influenced their decision. It is our
impression that when the parents realized they had been allocated to
the nonintervention group they lost their incentives to participate.
Four of these 6 infants were later transferred to other hospitals and
thus received different treatment. Thus, the intervention group
consisted of 12 infants and the control group of 13 subjects (Fig
1) with similar backgrounds (Table
1).
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Our findings are summarized in Table 2. The infants receiving care according to NIDCAP required significantly less ventilatory support, compared with the control infants. Four infants in the intervention group never required mechanical ventilation. In the control group, there was 1 infant who was extubated already after 2 hours. None of these infants were given surfactant. The respective mean values (standard deviation) for CPAP were 27.0 (12.0) versus 44.1 (16.5) days and for PCA at the time of oxygen withdrawal 32.9 (1.8) versus 38.1 (3.6) weeks. At 36 weeks of PCA, 6 of the infants in the NIDCAP group had mild signs of BPD on chest radiograph but none required supplementary oxygen. In the control group, there were 2 infants with mild, 4 with moderate, and 2 with more severe signs of BPD; all 8 needed extra oxygen. The mean head growth (standard deviation) up to 35 weeks of PCA was .80 (.22) in the NIDCAP group, compared with .63 (.07) cm/week among the controls.
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In addition to the primary outcomes, clinical observations of interest are summarized in Table 3. Hospital mortality for the NIDCAP group was 1/12 versus 2/13 for the controls. Furthermore, 1 infant in the control group died of Sudden Infant Death Syndrome at 8 months of age. No hydrocephalus, IVH of grade IV, or periventricular leukomalacia was observed in any of the subjects. There was 1 infant with IVH grade III in the NIDCAP group, compared with 3 such cases in the control group. There were 2 infants with symptomatic persistent ductus arteriosus (PDA) in each group. None of the differences in these observations were statistically significant.
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DISCUSSION |
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Top
Abstract
Methods
Results
Discussion
References
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Our results indicate that intervention according to NIDCAP does not have a negative impact on the care of VLBW infants and might even be advantageous. The mean duration of CPAP treatment was shortened by 17 days. None of the 11 infants in the NIDCAP group required supplementary oxygen at 36 weeks of PCA (ie, demonstrated chronic lung disease [CLD] of the premature), in comparison to 8/11 among the neonatal survivors of the controls.
The incidence of CLD in the control group could seem high. However, similar incidences in selective groups of VLBW infants have been documented in a recent report from our institution in which CLD was found to be associated with PDA and late-onset sepsis.43 There were no group differences in the incidences of these conditions, in the present study.
There was an indication of enhanced head growth in the intervention group. Although this is in agreement with the findings of Stevens and collaborators,30 this finding did not remain significant after the correction for multiple comparisons. Other variables, eg, weight gain, number of apneas, requirement for antibiotic treatment, and retinopathy of prematurity tended to be positively influenced by NIDCAP as well.
Four of the 21 infants initially assigned to NIDCAP care and none of the 20 infants assigned to conventional care were withdrawn from the study because they were too healthy, ie, did not fulfill the criteria of inclusion at 24 hours of age (see Fig 1). It might be speculated that NIDCAP is especially effective if applied immediately after birth.
This possible early effect was the reason for our randomization process. The parents were not blind to the allocation at the time of their final consent. Undoubtedly, it would have been preferable to obtain their decision before delivery or immediately at birth. Considering the acuteness of many premature births, this would not have been possible in all cases. Furthermore, we did not find it ethically correct to approach the parents in this psychological very hard moment, because the NIDCAP intervention very unlikely would cause the infants any discomfort or harm. This assumption was based on our earlier experience and the previous reports of others. The ethical board of the hospital approved this procedure.
There were 2 major reasons for terminating the trial before the desired number of subjects were obtained. Because the recruitment took a much longer time than anticipated, we noticed that the risk for a spillover effect to the control group increased. Nurses involved in NIDCAP care soon became convinced of its beneficial effects and, from time to time, exchanges of personnel between the 2 groups were necessitated by acute staffing problems. Furthermore, the staff of the controls was increasingly expressing feelings of discomfort and disloyalty, not being able to offer developmentally supportive care to their patients.
The introduction of NIDCAP is a multidisciplinary process involving not only medicine and nursing, but also developmental, family, and organizational psychology. NIDCAP requires some physical changes in the NICU, as well as considerable educational efforts. Evaluation of its effects is complicated by the complexity of the intervention. In comparison to studies involving different drug treatments, it is more difficult to achieve an optimal experimental design.
Consequently, many previous studies2530-32,44,45 on NIDCAP have been using a historical design. This fact has given rise to certain methodological concerns and doubts about the results obtained.35-37 To our knowledge, the present study is the first RCT outside of North America.
Despite our randomized design, certain problems were encountered. The attending neonatologists were not unaware of the infants' status in the study. However, decisions concerning ventilatory support were made according to guidelines by several different neonatologists not directly involved in the study. The first author in this study was not working at the unit involved and the nursing staff for the NIDCAP group was not composed of volunteers. In contrast, after these nurses had received general NIDCAP training and experienced observations involving care-giving plans and the general support of the NIDCAP-certified nurses, they probably influenced the need for ventilatory support. By being aware of the cues provided by the infants, they could suggest an appropriate time for terminating CPAP treatment and subsequently provide competent support for the infant's self-regulation of its different subsystems, including the autonomic system associated with respiratory regulation.
Our findings here are in line with previous studies. In an RCT from the era before surfactant treatment was used, Als et al27 reported positive effects of NIDCAP in the form of a reduced requirement for ventilatory support, a reduced incidence of IVH and CLD, improved weight gain, cost-savings, improved self-regulatory abilities, and improved mental and psychomotor development at 9 months of age. In a repeat study, in which surfactant treatment was also used, the Fleisher et al29 observed a reduced requirement for ventilatory support, improved behavioral performance and less chronicity in addition to cost-savings. In the follow-up study at 2 years of age, another group of investigators46 did not demonstrate improved development. However one third of the original subjects were lost from the study, implying possible sample bias and renders their follow-up data less reliable.
Both of these RCTs included only infants with a birth weight of <1250 g, <28 weeks of PCA, and who were ventilated mechanically for >24 hours starting within 3 hours after birth. Interestingly, when Buehler and associates28 examined a low-risk group of infants born between 30 and 34 weeks of PCA and not requiring mechanical ventilation, NIDCAP still improved behavioral, neurological, and electrophysiological maturation.
The complexity of developmentally supportive care and its demand for comprehensive training has caused some concern about its cost-effectiveness.35 However, several groups have reported that NIDCAP actually reduces costs by $4000 to 120 000 per infant,26,2729-32 depending on his/her birth weight and initial illness.
Concerns have been expressed that the implementation of this program would require extra nursing time. It is our experience45 that NIDCAP increases the competence of both staff members and parents. Care-giving is specifically adjusted to the current medical and developmental status of the infant. It might be speculated that the caregivers become more skilled and detect changes in the infant's status at an earlier stage. This might, in turn, lead to prompt intervention and prevention of additional deterioration. Thus, the infants become more physiologically stable and actually require less nursing time, which is in line with the findings of others.30,32
Our earlier study45 also indicated that environmental changes in the neonatal unit are not in themselves sufficient to explain the improvement observed. During periods without NIDCAP observations, we have experienced an obvious decline in the quality of care. Thus, to achieve improvements regular observations seem to be essential, although to what extent remains to be determined.
It is important to emphasize that not all personnel are suited to become NIDCAP observers. It requires a good deal of sensitivity to interpret the subtle signs of a premature infant and a great deal of psychological skill to interact with the staff and parents in such a manner that they feel supported and not criticized.
It should also be mentioned that implementation of developmental care in the hands of an unskilled person involves a potential risk of over-emphasizing the protection of the infant, ie, to forget the individualized portion of the program. NIDCAP ought not be implemented unreflectively, eg, by completely covering the isolette of a not-yet-stabilized infant, thereby preventing its necessary surveillance; by building containment for the infant that is too rigid; and by over-protecting a stable, competent baby from visual, auditory, and social input, thus preventing it from developing its own ability to self-regulate and interact socially. Instead, intervention should be designed from the viewpoint of each individual infant, ie, by attempting to determine what is appropriate for this particular infant at this particular time, considering all factors, including the infant's medical status.
Care and intervention based on the infant's own behavior seem attractive from an ethical point of view and, in addition, make good biological sense. Nurses and parents have implemented NIDCAP with great enthusiasm. Among neonatologists, there has been both praise and skepticism. Based on our own practical experience and on the findings in our limited study, we conclude that family-centered developmentally supportive care seems to be beneficial in a Swedish setting. Larger multicenter studies with follow-up programs are now warranted to further confirm the indications of the positive impacts of NIDCAP on VLBW infants.
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ACKNOWLEDGMENTS |
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This study was supported by the Vårdal Foundation, Dalarna Research Institute, Federation of County Councils, Smedby Foundation, Sällskapet Barnavård, Sunnerdahls Foundation, First of Mayflower Annual Campaign, and Solstickan Foundation.
The assessment of the chest radiograph examinations by Hedwig Wahlgren is gratefully acknowledged.
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FOOTNOTES |
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Received for publication Feb 9, 1999; accepted Aug 23, 1999.
Reprint requests to (B.W.) Department of Pediatrics, Umeå University Hospital, S-901 85, Umeå, Sweden. E-mail: bjorn.westrup{at}pediatri.umu.se
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ABBREVIATIONS |
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VLBW, very low birth weight (<1500 g); BPD, bronchopulmonary dysplasia; NIDCAP, Newborn Individualized Developmental Care and Assessment Program; RCT, randomized controlled trial; PCA, postconceptional age; CPAP, continuous positive airway pressure; CRIB, Clinical Risk Index for Babies; IVH, intraventricular hemorrhage; PDA, persistent ductus arteriosus; CLD, chronic lung disease; NS, not significant.
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REFERENCES |
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