Positive effects from individualized developmental care on healthy, pre-term infants in NICU
Treatment using the Newborn Individual Developmental Care and Assessment Program (NIDCAP) as compared to standard care for low-risk pre-term infants during time in the neonatal intensive care nursery (NICU) makes a clinically important improvement in their neurobehavioral functional level of development at corrected ages of 2 weeks and 9 months.
Level of Evidence 1b.
Citation/s: Als H, Duffy FH, McAnulty GB, Rivkin MJ, Vajapenyam S, Mulkern RV, Warfield SK, Huppi PS, Butler SC, Conneman N, Fischer C, Eichenwald EC. Early Experience Alters Brain Function and Structure. Pediatrics. 2004. 113(4):846-57.
Lead author's name and e-mail: Heidelise Als, PhD.
Three-part Clinical Question: A review of the cited article was completed with the focus on the techniques of neuroimaging used to study brain structural changes as related to very early experience. The article is now being critically analyzed from the standpoint of effectiveness of the therapeutic early experience on functional behavioral outcomes.
Is developmentally supportive care (NIDCAP) more effective than standard care for improving function in a healthy, preterm infant girl with a corrected age of 1 week?
Search Terms: This article had previously been located for purposes of neuroimaging review using the terms "MRI AND infants AND development" on PubMed Clinical Queries for therapy with a narrow, specific search, where the title "Early experience alters brain function and structure" was the most appealing title of 9 articles found on the search. Searching using the above clinical question with the terms "NIDCAP AND premature infants" on PubMed Clinical Queries with a narrow, specific search in the category of therapy yielded 9 articles including the Als article.
The Study: Single-blinded concealed randomized controlled trial with intention-to-treat.
The Study Patients: Medically healthy, pre-term (28-33 week gestation) infants (born to mothers who had prenatal care) with 5-minute Apgar score>=7; weight and head circumference at birth appropriate for gestational age (between 5th and 95th percentile; normal initial cranial ultrasound, MRI, and/or EEG; <=72 hours of ventilator support; <=72 hours of vasopressor medication; free of congenital or chromosomal abnormality, congenital or acquired infection, prenatal brain lesions, and neonatal seizures. Family selection criteria included residence in the greater Boston area; mothers >=14 years; absence of major maternal medical or psychiatric illness, or chronic medication treatment, or history of substance abuse at any time (including alcohol or tobacco), family accessibility by telephone, and some English-language facility. The infants were randomly assigned to control and experimental groups dependent on gender and ethnicity.
Control group (N = 14; 14 analyzed): These 15 infants received "standard care" practiced at the time of the study at the Brigham and Women's Hospital NICU, which included an effort at primary care nursing and staff-dependent inconsistent parent inclusion, uniform shielding of incubators with white hospital blankets, early use of dressing in T-shirts, and side and foot rolls: liberal provision of pacifier; and inconsistent nurse-dependent encouragement of skin-to-skin holding (kangaroo care) and breastfeeding. The control group received this standard care for the duration of their NICU stay.
Experimental group (N = 16; 16 analyzed): The 18 infants of the experimental group received care consistent with the Newborn Individualized Developmental Care and Assessment Program (NIDCAP) approach. This approach to care involved individualized intervention consisted of daily observation and weekly evaluations of the infants' behavior by developmental specialists (a trained psychologist and neonatologist), with suggestions for parents and staff in terms of ways to support each infant's development. The developmental specialist used their formal observations of 91 behaviors to formulate descriptive neurobehavioral reports and suggestions to structure care giving procedures to the infant's sleep/wake cycle, to maintain the infants' well-regulated autonomic, motor, and organization behavioral balance. They also had daily contact with the infants' caregivers to provided ongoing support for the care teams and parents in jointly planning and implementing individually supportive care. The care plans were facilitated by the NICU's nurse managers and medical directors. The nurses caring for the experimental group were trained in this developmental care approach. NIDCAP includes the use of the infant "tuck" by swaliling to position the infants in a more curled up position using soft blankets, beliing, individually sized buntings; supportive holding in the tucked position and crauling in the caregiver's hands; individually adjusted beliing including use of natural sheepskins, terry cloth buntings, soft, special-sized, appropriate body and hugging pillows, and soft special pacifiers; bathing in swalile blankets in deep, arm water; weighing while swaliled, providing a second caregiver to support the infant during stressful procedures such as suctioning, chest radiographs, and cranial ultrasounds; increasing darkness and quiet for the infant; and supporting the parents in caring for their infant, nursing, and holding their infant in restful, skin-to-skin contact for prolonged periods of time in comfortable recliner chairs in which to relax and hold and sleep with their infants; encourage the parents to personalize their infant's bed area, provide muted, indirect lighting, encouraged parents and staff to make use of custom-made attractive, soft-colored "privacy screen" and crib canopies. The NIDCAP interventions started at the phase of the infant's initial stabilization and then every 7 days throughout hospital discharge and to 2 week's corrected age
The Evidence:
Outcome / Time to Outcome / CER / EER / RRR / ARR / NNTPneumothorax / 2 weeks corrected age / 0.143 / 0 / 100% / 0.143 / 7
95% Confidence Intervals: / -0.040 to 0.326 / NNT = 3 to INF;
NNH = 25 to INF
Intraventricular Hemorrhage / 2 weeks corrected age / 0 / 0.063 / INF / -0.063 / -16
95% Confidence Intervals: / -0.182 to 0.056 / NNT = 18 to INF;
NNH = 5 to INF
Bronchopulmonary Dysplagia / 2 weeks corrected age / 0.071 / 0.188 / -165% / -0.117 / -9
95% Confidence Intervals: / -494% to 100% / -0.351 to 0.117 / NNT = 9 to INF;
NNH = 3 to INF
Measure / Control Group / Experimental Group / Difference / 95% CI
Mean / SD / Mean / SD
Weight At Birth, g / 1730 / 350 / 1648 / 232 / 82 / -137 to 301
Head circumference / 36.70 / 0.75 / 36.75 / 1.18 / -0.050 / -0.80 to 0.70
5 min. Apgar score / 8.5 / 0.52 / 7.88 / 0.081 / 0.620 / 0.35 to 0.89
Weight at 2 weeks corrected age, g / 4095 / 518 / 3999 / 400 / 96 / -248 to 440
Head Circumference 2 weeks corrected age / 36.70 / 0.74 / 36.75 / 1.12 / -0.050 / -0.77 to 0.67
Total Prechtl at 2 weeks corrected age / 38.30 / 9.55 / 17.33 / 15.52 / 20.970 / 11.16 to 30.78
MDI at 9 months corrected age / 94.85 / 9.22 / 109.55 / 7.23 / -14.700 / -21.82 to -7.58
PDI at 9 months corrected age / 89.23 / 14.88 / 107.00 / 9.28 / -17.770 / -28.51 to -7.03
BRS, total score at 9 months corrected age / 39 / 23 / 73 / 16 / -34 / -51.10 to -16.90
Comments: Are the Results Valid? This study was a controlled trial design with 2-group randomization. Subjects randomly assigned to either control or experimental group. Assignment was revealed by parental opening of prenumbered, sealed envelope drawn from the respective randomization box, dependent on the infant?s gender and ethnicity (blocked a priori). Allocation of group assignment remained concealed from the assessment staff, this included double-blinding of the pediatrician who derived the medical information from the charts, double-blinding of the psychologist who interviewed the parents in order to obtain any missing demographic or medical data, blinding of the evaluator who performed the neurobehavioral assessments at 2 weeks? corrected age, and blinding the two independent examiners who performed the 9 months? corrected age neurobehavioral assessments. Randomization of the groups showed to be equal with no significant differences noted in medical and demographic variable, note the birth weight and head circumference means with 95% CIs that include the null value for between-group mean differences. There was a statistical difference between the two groups based on ethnicity where 8/14 or 0.57 estimated population proportion with 95%CI (.33 to 79) were Caucasian and 15/16 or 0.97 estimated population proportion with 95% CI (.72 to .99) showing a no difference between groups (comparison of proportions or olis ratio of 11.25 with 95% CI (1 to 110), 1 is null and included for olis ratios. The only medical background variable that was statistically different between the control and experimental groups was the 5 minute Apgar, where the experimental group had a 0.62 point lower average being significant with 95%CI (.35 to .89). Intention to treat the experimental group was conducted with 100% consistency according to observation reports. Nurse work records which showed that the experimental group infants (mean 53%) were cared for by nurses rated as developmentally skilled for more hours/shifts (F=11.06, df=1,18; P=.004) in the course of their hospitalization than the control group (38%) . There is a threat to validity in that the intention to treat the control group with standard care had no formal effort to prevent spillover effects from the experimental group. The authors report that the experimental treatment effect on the control group as a conservative influence or not beyond the inevitable spillover where both infant groups were in the same NICU being cared for at the same time. Assigning the control infants to a separate nursery with nurses trained only in standard care would have strengthened the certainty of the standard care regime for the control group. Follow-up at the 2 weeks? corrected age included all 30 infants of the study. At the time of the 9 months? corrected age outcomes measures, 1 control (6%) and 5 experimental (36%) infants were lost from follow-up/did not return for assessment because of family scheduling conflicts.
What are the Results? The purpose of the study was to explore the effects of the NIDCAP intervention on low-risk preterm infants. The authors also reported some events to include pneumothorax, interventricular hemorrhage, and brochopulmonary dysplagia. There was significant improvement in the neurobehavioral tests done at both 2 weeks? and 9 months? corrected age. The size effect of the BRS total score at 9 months was large at 1.7 (mean score experimental group ? mean score control group/standard deviation: 73-39/20). The size effect of the Prechtle was large at 1.7 (38.30-17.33/12.5). The scores of the experimental group on the MDI and PDI (Bayley II) were clinically important differences with improvements equal to twice the standard deviations.
How Can I Apply the Results to Patient Care? The infants in this study differ from my infant patient in that they were all treated in the NICU, and my patient, is in the home setting, 4 weeks after hospital discharge at beginning care at corrected age of 1 week. The study showed that there were significant differences in the neurobehavioral function of the infants that received the individual developmental care in those very early days and weeks in the NICU at periods of time before 36 weeks gestational age. The article also described other clinical outcomes related to significant correlation of improvements in brain function and brain structural maturity in the experimental group. Therapy intervention using some of the NIDCAP care techniques for this infant may be indicated if the infant is having autonomic (breathing, heart rate, color changes, and visceral signs), motor (postures, muscle tone fluctuations, or movements), or state organizational difficulties (levels of arousal, patterns of transitions between states, and clarity and robustness of sleep and awake states). Other studies would need to be found to answer whether or not it is too late in the brain development of my infant patient for NIDCAP to be effective.
Appraised by: Dawn Stanuley, November 03, 2007 Email: