PEDIATRICS Vol. 100 No. 6 December 1997, p. e9
,
, and
From the * Department of Pediatrics, Stanford University School
of Medicine, Stanford, California; the
University of Connecticut,
Storrs, Connecticut; the § University of Lyon, Lyon, France; and
Netherland Institute of Brain Research, Amsterdam, The Netherlands.
Objective. The Neonatal Individualized Developmental Care Program (NIDCAP) for very low birth weight (VLBW) preterm infants has been suggested by Als et al to improve several medical outcome variables such as time on ventilator, time to nipple feed, the duration of hospital stay, better behavioral performance on Assessment of Preterm Infants' Behavior (APIB), and improved neurodevelopmental outcomes. We have tested the hypothesis of whether the infants who had received NIDCAP would show advanced sleep-wake pattern, behavioral, and neurodevelopmental outcome.
Methods. Thirty-five VLBW infants were randomly assigned to receive NIDCAP or routine infant care. The goals for NIDCAP intervention were to enhance comfort and stability and to reduce stress and agitation for the preterm infants by: a) altering the environment by decreasing excess light and noise in the neonatal intensive care unit (NICU) and by using covers over the incubators and cribs; b) use of positioning aids such as boundary supports, nests, and buntings to promote a balance of flexion and extension postures; c) modification of direct hands-on caregiving to maximize preparation of infants for, tolerance of, and facilitation of recovery from interventions; d) promotion of self-regulatory behaviors such as holding on, grasping, and sucking; e) attention to the readiness for and the ability to take oral feedings; and f) involving parents in the care of their infants as much as possible. The infants' sleep was recorded at 36 weeks postconceptional age (PCA) and at 3 months corrected age (CA) using the Motility Monitoring System (MMS), an automated, nonintrusive procedure for determining sleep state from movement and respiration patterns. Behavioral and developmental outcome was assessed by the Neurobehavioral Assessment of the Preterm Infant (NAPI) at 36 weeks PCA, the APIB at 42 weeks PCA, and by the Bayley Scales of Infant Development (BSID) at 4, 12, and 24 months CA.
Results. Sleep developmental measures at 3 months CA showed a clear developmental change compared with 36 weeks PCA. These include: increased amount of quiet sleep, reduced active sleep and indeterminate sleep, decreased arousal, and transitions during sleep. Longest sleep period at night showed a clear developmental effect (increased) when comparing nighttime sleep pattern of infants at 3 months with those at 36 weeks of age. Day-night rhythm of sleep-wake increased significantly from 36 weeks PCA to 3 months CA. However, neither of these sleep developmental changes showed any significant effects of NIDCAP intervention. Although all APIB measures showed better organized behavior in NIDCAP patients, neither NAPI nor Bayley showed any developmental advantages for the intervention group. The neurodevelopmental outcome measured by the Bayley at 4, 12, and 24 months CA showed 64% of the NIDCAP intervention group at the lowest possible score compared with 33% of the control group. These findings could not be explained by the occurrence of intraventricular hemorrhage or the socioeconomic status of the parents, which showed no significant group effect.
Conclusion. The results of this study, including measures of sleep maturation and neurodevelopmental outcome up to 2 years of age did not demonstrate that the NIDCAP intervention results in increased maturity or development.
Buehler et al (Pediatrics. 1995;96:923-932) have reported that premature infants (N = 12; mean gestational age 32 weeks, mean birth weight 1700 g) who received developmental care compared with a similar group of infants who received routine care showed better organized behavioral performance on an APIB assessment at 42 weeks PCA. None of the medical outcome measures were significantly different in this study. Although our APIB results are in agreement, the results of the NAPI, the Bayley and sleep measures do not show an increase in neurodevelopmental maturation. In the earlier report by Als et al (Journal of the American Medical Association. 1994;272:853-858), both medical and neurofunctional improvements were found in very low birth weight premature infants (mean gestational age 27 weeks, mean birth weight ~870 g) in which 20 infants who received NIDCAP were compared with 18 infants who received routine care. At 42 weeks PCA the APIB was better in the intervention group as was the Bayley at 6 months CA. Later neurodevelopmental assessments in this study population have not been reported. Furthermore, as was indicated in the editorial by Merenstein in the same issue of the Journal of the American Medical Association, a significant problem with the study was that the number of intraventricular hemorrhages was higher in the control group (10 of 18 vs 1 of 20) and the study was conducted before the widespread use of surfactant and prenatal steroids. The study was performed in a single nursery with nurses who volunteered for developmental intervention and cared for the experimental group. No assessment was performed on differences in nursing, intervention, lighting, or sound between the two groups. Apnea, bradycardia, and desaturation data were not reported also. NIDCAP has been shown to reduce stress and agitation in the infants in our study (Heller C, et al. Journal of Perinatology. 1997;17:107-112); however, there was no difference in the incidence of apnea or bradycardia.
Additional studies are needed to determine which specific interventions facilitate recovery in the high-risk preterm infant when interventions are efficacious, what may be adverse or ineffective, and what mechanisms are involved. Distinctions should be made between medical improvement, neurobehavioral responses (APIB), and neurodevelopmental maturation. Not only the duration of NICU hospitalization, but indeed, long-term outcomes must be carefully evaluated. We recommend that clinicians should be aware that preterm infants who have received NIDCAP during their hospitalization do not appear to be more mature at the time of discharge home.
Key words: sleep, circadian rhythms, NIDCAP, neurodevelopment, infants.The Neonatal Individualized Developmental Care and
Assessment Program (NIDCAP) for very low birth weight (VLBW) [
1250
g] neonatal intensive care unit (NICU) infants has been shown to decrease the need for mechanical ventilation, shorten the time to full
enteral or bottle/breast feedings, decrease hospital days, lower
charges for hospital care, and improve behavioral organization. Some
early (9 months corrected age [CA]) developmental outcome also favors
the intervention group.1 Fleisher and
co-workers4 from our NICU had designed a study to verify
the effectiveness of developmental intervention in our practice. The
purpose of the present study was to determine if the improvement in
medical outcomes was associated with improved sleep or developmental
outcome.
Subjects
Infants in this study met the enrollment criteria for the above mentioned report4: a) birth weight
1250 g; b)
gestational age (GA)
30 weeks; c) mechanical ventilation begun in the
first 3 hours and continued for more than 24 of the first 48 hours of life; d) singleton or sole survivor of multiple gestation; e) no
chromosomal or major genetic anomalies; f) no congenital infection; and
g) parents' willingness to participate in long-term follow-up after
discharge. Forty subjects entered during the 2-year (1992 to 1994)
study of the effects of individualized care. Five of the enrollees
died. Twenty-eight of the 35 surviving infants were available for sleep
studies as our recruitment for this component of the study began in
October 1992 and 23 were seen at 2 years CA. The maternal and neonatal
characteristics are shown in Table 1.
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Table 1. Neonatal and Demographic Information (Mean, SD) for 28 Patients Undergoing Sleep Studies |
The NIDCAP Intervention
The details for the NIDCAP intervention have been described in detail in previous publications.1 The goals for NIDCAP intervention were to enhance comfort and stability and to reduce stress and agitation for the infants by: a) altering the environment by decreasing excess light and noise in the room and by using covers over incubators and cribs; b) use of positioning aids such as boundary supports, nests, and buntings to promote a balance of flexion and extension postures; c) modification of direct hands-on caregiving to maximize preparation of infants for, tolerance of, and facilitation of recovery from interventions; d) promotion of self-regulatory behaviors such as holding on, grasping, and sucking; e) attention to the readiness for, and the ability to take oral feedings; and f) involving parents in the care of their infants as much as possible. The intervention was closely monitored by certified developmental specialists.4Procedures for Sleep Recordings
The sleep of all 28 infants was recorded for 48 hours at least once. Twenty-four infants were monitored in the hospital at 36 weeks postconceptional age (PCA), 25 infants were monitored in the home at 3 months CA, and 21 infants were recorded at both ages. The infant's sleep was recorded using the Motility Monitoring System (MMS), an automated, nonintrusive procedure that has been described in detail in previous reports from E. Thoman's (ET) laboratory.6 These reports provide evidence for reliability and validity of the measures of sleep obtained from the MMS recording procedure. Briefly, the system consists of a capacitance-type sensor pad that was placed in the infant's crib under the bedding. The pad was connected to a battery-powered amplifier and a recorder. A single channel analog signal produced by the infant's respiration and body movements was continuously recorded for 2 consecutive days. No changes in caregiving, other than ensuring optimal pad placement, were needed as nothing was attached to the infant. The recordings were processed by ET's laboratory where data were downloaded to a computer and scored in 30-second epochs for sleep/wake states, using a pattern recognition program. ET was not informed of the infant group assignments. The five states scored were: Active Sleep (AS), Active-Quiet Transition Sleep (A-Q-Tr), Quiet Sleep (QS), Sleep-Wake Transition (S-W-Tr), and Wakefulness (W) during the time in crib (TIC). Examples of signals for four of these states are presented in Fig 1.
Measures Obtained From MMS Sleep Recordings
For each 24-hour recording, the times spent in AS, QS, and A-Q-Tr were calculated and expressed as a percentages of the total sleep time. Times spent in S-W-Tr and W were calculated and expressed as a percentages of the TIC. In addition to percentages for the above five states, the following measures were calculated for each recording: TIC The amount of time spent in the crib as a percent of the total recording time (24 hours). Arousal in QS (Ar-in-QS) Movement that occurred during QS for at least 25 seconds. According to the rule of 3 minutes for a state change, if the arousal persisted for as long as 3 minutes, a change in state (to wakefulness) was scored. Arousal in AS (Ar-in-AS) Movement that occurred during AS for at least 25 seconds. According to the rule of 3 minutes for a state change, if the arousal persisted for as long as 3 minutes, a change in state (to wakefulness) was scored. Mean Bout Length of QS (QS-BL) Mean duration of all bouts of QS in the 24-hour recording. If a bout of QS occurred at the beginning or end of a period in the crib, it was included in the calculation of the mean QS-BL only if the length of that bout was equal to or greater than the median of all bout lengths of QS for the recording. Mean Bout Length of AS (AS-BL) Mean duration of all bouts of AS in the recording. If a bout of AS occurred at the beginning or end of a period in the crib, it was included in the calculation of the mean AS-BL only if the length of that bout was equal to or greater than the median of all bout lengths of AS for the 24-hour recording. This adjustment was made to diminish the effects of the mother's putting the infant in the crib or picking the infant up during AS. Active Sleep/Quiet Sleep Ratio (AS:QS) Ratio of Active Sleep to Quiet Sleep.Longest Sleep Period (LSP) at Night and Day-Night Rhythm of Sleep
We were also interested in examining the effect of NIDCAP intervention on the development of settling or sleeping through the night. Conventionally, an infant is developmentally matured and settled at night when (s)he sleeps without waking during the hours from 12 midnight to 5 AM, usually the time when parents are asleep. To measure this we have calculated, according to Anders and Keener,12 the percentage longest sleep period (%LSP) (ie, number of minutes of sleep divided by 300 multiplied by 100). Another important developmental change in the organization of sleep-wake patterns is the appearance of diurnal (or circadian) rhythms.10,13,14 As an adjunct of circadian rhythm development, sleep becomes more consolidated at night and wakefulness increases during the day. The degree of circadian rhythm maturation can be assessed by dividing the recording into subjective day (7 AM to 7 PM) and subjective night (7 PM to 7 AM) and expressing the amount of sleep as percentages of each 12-hour period. Two measures of sleep consolidation were determined to evaluate the effect of NIDCAP on the diurnal sleep pattern. The first was to determine the time of day in which the LSP occurred and to express it as a percentage. The second was to arbitrarily divide the 24-hour period into 07:00 to 19:00 (daytime) and 19:01 to 06:59 (nighttime) and express these as percentages of the 12-hour periods. Analyses of variance (ANOVAs) were performed on both of these measures.Neurobehavioral Assessment of the Preterm Infant (NAPI)
The NAPI15 is a measure of relative neurological maturity and consists of seven cluster scores: 1) scarf sign, 2) popliteal angle, 3) motor development, 4) alertness and orientation, 5) irritability, 6) cry quality, and 7) percent asleep. The unique characteristic of the NAPI is that it uses an invariant sequence of item presentation, so that reliable comparisons can be made between subjects or groups of subjects and on repeated assessments on the same individual.16 Thirty-one infants were tested at 36 weeks PCA. Four were too fragile to be tested.Assessment of Preterm Infants' Behavior (APIB)
The APIB17,18 measures the organization of the infant's behavior in five items including the autonomic, motor, state, attentional, and self-regulatory systems. The amount of examiner facilitation is also assessed. Thirty-five infants in this study were tested at 42 weeks PCA.Bayley Scales of Infant Development (BSID)
The BSID19 is a standardized evaluation of the developmental status of children from 1 to 42 months of age providing separate scores for mental function reported as the Mental Developmental Index and motor function reported as the Psychomotor Developmental Index. After 24 years the Bayley has been renormed in 1993 to correct the upward drift and to more accurately reflect the diversity of our current population.20 The BSID II edition was released during the course of our study and was used for the infants assessed at 24 months. Twenty-three of the original 35 infants in this study were tested at 24 months CA. The infants lost to follow up were less severely ill than those who were seen and there were no intergroup differences in severity of illness.Sleep
As indicated in Table 2 and Fig 2, the following states changed significantly over age: %AS decreased, %QS increased, %AS:%QS decreased, %S-W-Tr decreased, Ar-in AS decreased, Ar-in-QS decreased and %LSP increased (see Table 3). %A-Q-Tr, %W, AS-BL, and QS-BL were not significantly different, though the AS-BL decrease in the intervention infants was nearly significant. TIC was less at 3 months CA and the amount of time asleep in crib is greater which supports that the parents usually placed their infant in the crib to sleep. The percent time awake while in the crib was similar in both groups. There were similar sleep, sleep/wake transitions, and arousals in both groups but significantly fewer arousals at 3 months CA in both active and quiet sleep. Quiet sleep bout length had a trend for increase with age and active sleep bout length had a trend for decrease at 3 months CA. A two-factor ANOVA on LSP, expressed in % of the period between midnight and 5 AM, yielded no significant effect of NIDCAP intervention alone or with age and the intervention. However, there was a significant age effect; NIDCAP 76 ± 14% at 36 weeks PCA, 91 ± 9% at 3 months PCA and Control 74 ± 13% at 36 weeks PCA, 88 ± 9% at 3 months PCA (Fisher's protected least significant difference (PLSD) P = .0005). No significant NIDCAP intervention effects were seen on sleep parameters.|
Table 2. Sleep Analysis Summary (Unpaired t Tests; N = NIDCAP Group; C = Control Group) |
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Table 3. Percentage Sleep During Day (07:00 to 19:00) and Night (19:00 to 07:00) Periods |
Behavioral and Developmental Assessments
NAPI Thirty-one of the 35 infants in the NIDCAP study were tested with the NAPI assessment at 36 weeks PCA. Four infants were still mechanically ventilated and too fragile to be tested.
Table 4.
NAPI Cluster Scores
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Table 5. APIB System Scores (Mean ± SD) |
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Table 6. Bayley Scores, adjusted for age (Unpaired t Test) |
Received for publication Jun 4, 1997; accepted Jul 24, 1997.
Reprint requests to (R.L.A.) Department of Pediatrics, Stanford University School of Medicine, Stanford, CA 94305-5119.
This work was supported by National Institutes of Health Grant HD29732, by a grant (MO1-RR00070) from the National Institutes of Health, by the Children's Health Council, by a grant from the David and Lucile Packard Foundation, by the Mary L. Johnson Research Fund, by Bloomingdale's Fund, and Netherlands Wetenschappen Onderzoek, The Netherlands.
We thank David K. Stevenson for his review of this paper.
NIDCAP, Neonatal Individualized Developmental Care and Assessment Program. VLBW, very low birth weight. NICU, neonatal intensive care unit. CA, corrected age. PCA, postconceptional age. MMS, Motility Monitoring System. ET, E. Thoman (Laboratory). AS, active sleep. A-Q-Tr, active-quiet transition sleep. QS, quiet sleep. S-W-Tr, sleep-wake transition. W, wakefulness. TIC, time in crib. LSP, longest sleep period. ANOVA, analysis of variance. NAPI, Neurobehavioral Assessment of the Preterm Infant. APIB, Assessment of Preterm Infants' Behavior. BSID, Bayley Scales of Infant Development.
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