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A neurobehavioral intervention and assessment program in very low birth weight infants: outcome at 24 months

A Neurobehavioral Intervention and Assessment Program in Very Low Birth Karen Koldewijn, PT, Aleid van Wassenaer, MD, PhD, Marie-Jeanne Wolf, PhD, Dominique Meijssen, MSc, Bregje Houtzager, MSc, PhD, Anita Beelen, PhD, Joke Kok, MD, PhD, and Frans Nollet, MD, PhD Objective To determine whether the Infant Behavioral Assessment and Intervention Program (IBAIP) improvesdevelopment and behavior in very low birth weight (VLBW) infants at 24-month corrected age.
Study design In a multicenter, randomized, controlled trial 86 infants received postdischarge intervention until 6-month corrected age. The intervention consisted of supporting infants’ self-regulation and development, and facil-itating sensitive parent-infant interactions; 90 control infants received regular care. At 6 months, positive interven-tion effects were found. At 24 months, development and behavior were evaluated with the Bayley Scales of InfantDevelopment-II (BSID-II) and the Child Behavior Check List (CBCL).
Results Eighty-three intervention and 78 control infants were available for follow-up. After adjustment for differ-ences in perinatal characteristics, an intervention effect of 6.4 points (Æ standard error, 2.4) on the PsychomotorDevelopmental Index favored the intervention infants. Groups did not differ on the Mental Developmental Index,the Behavioral Rating Scale of the BSID-II, or on the CBCL. Subgroup analyses revealed improved motor as wellas improved mental outcomes in intervention infants with bronchopulmonary dysplasia and with combined biolog-ical and social risk factors.
Conclusions The IBAIP shows sustained motor improvement in VLBW infants until 2-year corrected age. (J Pe-diatr 2010;156:359-65).
Growingconcernaboutthedevelopmental,social-emotional,andhealthproblemsinverypreterminfantsthatpersist into early adulthoodhave led to the design of various types of early postdischarge intervention programs that aim toimprove the long-term outcome of these children. Recent meta-analysereported a significant impact of postdi- scharge intervention on cognitive outcomes at infant and preschool age. There is heterogeneity of the programs, and furtherstudies are needed to identify intervention components that are most effective. Apart from biological factors, the infant’s self-regulatory competenceas well as parental sensitivity and responswere noted as crucial for the quality of parent-infant interactions. These, in turn, influenced the infant’s developmental course after preterm The Infant BehavioralAssessment and Intervention Program ), based on the synactive theory by Als,is designed to support infants withdevelopmental risk from term to approximately 8 months of age. This program aims to support the infant’s self-regulatorycompetence as well as the infant’s multiple developmental functions in an integrative way, via responsive and positive par-ent-infant interactions. We conducted a randomized, controlled trial to study the effect of the IBAIP on very low birth weightinfants (VLBW). At 6-month corrected age, we found that the program improved the mental, motor, and behavioral outcomesof VLBW infants.Neurobehavioral assessment demonstrated increased attention and engagement in interactions over time,accompanied by less stress behavior in the intervention infants compared with control infants. The principal outcome measuresof our trial were child development at 6 months, shortly after termination ofthe intervention, and at 24 months. We report infant outcomes at 24-monthcorrected age.
From the Department of Rehabilitation (K.K., M.-J.W.,A.B., F.N.), the Department of Neonatology (A.v.W.,M.-J.W., B.H., J.K.), Academic Medical Center,University of Amsterdam, The Netherlands; and theDepartment of Pediatric Psychology (D.M.), TilburgUniversity, Tilburg, The Netherlands Supported by grants from the Innovatiefonds Zorgver- zekeraars (project No. 576) and ZonMw (Zorg OnderzoekNederland) (project No. 62200032). Innovatiefonds Zorgverzekeraars supported the implementation of the intervention program, and Zorg Onderzoek Nederland supported the first author, who wrote the first draft of themanuscript. The sponsors had no involvement in study design; collection, analysis, or interpretation of the data; writing of the report; or the decision to submit the man-uscript for publication.
0022-3476/$ - see front matter. Copyright Ó 2010 Mosby Inc.
All rights reserved. 10.1016/j.jpeds.2009.09.009 THE JOURNAL OF PEDIATRICS  www.jpeds.com Neurobehavioral intervention focuses on overall develop- mental and behavioral support. In line with the outcomemeasures at 6 months, the Dutch version of the Bayley Scales The Medical Ethics Committee of all hospitals involved ap- of Infant Development-II (BSID-II) was used to assess infant proved the study design. We carried out a multicenter, random- developmA mental developmental index score (MDI) ized, controlled trial in 7 Amsterdam hospitals. Infants with and a psychomotor developmental index score (PDI) were gestational ages (GA) of <32 weeks and/or birth weights of calculated for the corrected age of the child. MDI and PDI <1500 g, with parents living in Amsterdam, were eligible for in the normal population have a mean of 100 (SD, 15). Ob- the study. Infants with severe congenital abnormalities, infants servations of infants’ behavior during the developmental test whose mothers had a documented history of illicit drug use or administration were rated using the Behavior Rating Scale severe physical or mental illness, infants from non–Dutch- (BRS) of the BSID-II. According to the Dutch manual, the speaking families for whom an interpreter could not be percentile scores of the ‘‘orientation/engagement and emo- arranged, and infants who participated in other trials on postdi- tional regulation’’ factor and the ‘‘motor quality factor’’ scharge management were excluded. Randomization into a con- were studied separately and summed up to a total score, trol or intervention group was computer-generated, stratified with higher scores on the BRS reflecting more adequate test- for GA (<30 and $30 weeks) and recruitment site. Interven- ing behavior. A score of $26 is classified as normal, 25 to 11 is tions were carried out by 6 experienced pediatric physical ther- questionable, and #10 is nonoptimal test behavior.
apists who had received 1 year of training in the IBAIP from the The Dutch version of the Child Behavior Check List 11⁄ author of this program (Rodd Hedlund). IBAIP training in- 5 (CBwas used to evaluate the child’s behavioral and volved the reliable assessment and support of neurobehavioral socio-emotional performance, as rated by the parent. It is competence, the facilitation of affective, social, cognitive, and a standardized questionnaire with good reliability and valid- motor functioning of the infant in an integrated way, and the ity, containing 100 items on problem behavior occurring use of a strength and process-based approach to support the now or in the previous 2 months. An Internalizing, External- parent-infant relationship. A detailed written report with rec- izing, and a Total problem score can be calculated. Raw ommendations was provided to the parents after every session.
scores are transformed into T-scores, accounting for differ- These reports, along with regular contact with the supervisor ences in sex and age. A T-score of <60 is classified as normal, (K.K.) and monthly reflection sessions, served to maintain the 60 to 63 is borderline, and >63 is in the clinical range.
The neurological examination according to Touwenwas Intervention infants and their parents received 1 IBAIP used to examine neurological functioning at 24 months. Ab- session shortly before discharge and 6 to 8 home interven- normal development is severe abnormality of tone, posture, tions until the baby was 6 months of corrected age. Control and movement leading to an impairment and/or delay in infants received standard care and, if required (non-IBAIP motor development. Mildly abnormal development is a mod- trained), pediatric physical therapy. Regular outpatient visits erate abnormality of tone, posture, and movement leading to to the pediatrician were standard in both intervention and a minor impairment and/or minor developmental delay.
Perinatal variables were taken from the medical records at The content of the IBAIP has been more extensively de- discharge. GA was determined by maternal history and ultra- scribed elseand is available from the Internet.
sound examination in early pregnancy and confirmed post- The implementation of the IBAIP by pediatric physical ther- natally with the Dubowitz-score if antepartum information apists resulted in a comprehensive intervention model in was inconclusive.Bronchopulmonary dysplasia (BPD) which ‘‘prevention’’ and ‘‘treatment’’ overlapped to a large was defined as moderate to severe BPD when the infant extent, supporting the parents as well as the evolving in- was oxygen dependent $36 Sociodemographic fant-parent relationship and the infant’s emerging functions.
data were obtained by a parent questionnaire. A multiple Guided by the infant’s behavior, the interventionist provides risk factor was created to explore the possible additive effect suggestions to encourage parents to support their infant’s of biological and social risk, including low maternal educa- self-regulatory efforts and/or competence; to adjust the tion and abnormal cranial ultrasound and/or BPD.
environment to their infant’s needs; to support positiveparent-infant interactions; and to enhance postural controland successful infant explorations without distress. Parents were given detailed information about their infant’s develop- At 24-month corrected age, pediatric, neurological, and de- ment to guide parents along their infant’s next developmen- velopmental assessment took place at the follow-up clinic tal steps and to support realistic expectations of their child’s of the Academic Medical Center and was carried out by an functioning. Central to the IBAIP intervention is the support experienced pediatrician and psychologist, blinded for group of the parent to raise their child. In addition, mindful atten- assignment. Parents were aware of the group assignment and tion to their infant’s behavioral expressions and development were instructed not to inform any of the outcome assessors.
may enhance the parents’ emotional availability, intrinsic The CBCL was sent to the parents 2 weeks before the follow- motivation, feelings of joy, and confidence in themselves up visit, to be completed by the parent that was most respon- sible for the care-taking of the child.
315 eligible participants
refused to participate (38)died (11)child factors (12)language reasons (11)parental factors (12) 176 randomized
older brother/sister in trial (3)participating in other trial (52) 86 intervention infants
90 control infants
85 received intervention/ 1 did not receive Follow-up at 6 months: 86
Follow-up at 6 months: 85
Follow-up at 24 months: 83
Follow-up at 24 months: 78
withdrawn (1); moved to other country (2) died (1); withdrawn (2); moved to other country (2); lost to follow up (2) ing significantly between the intervention and control group Primary outcome measures were the MDI and PDI of the (the use of indomethacin, dopamine, surfactant, and septic BSID-II. Secondary outcomes were the BRS, CBCL, and neu- Secondary analysis of the MDI and PDI were performed to explore the interaction between intervention and BPD, cra- nial ultrasound abnormality, gestational age, low maternal The sample size for this trial was selected to provide 90% education, as well as multiple risk (low maternal education power to detect a difference between intervention and con- and abnormal cranial ultrasound and/or BPD). Post hoc trol groups in BSID-II (PDI and/or MDI) at 6-month cor- t tests were performed to compare the outcomes of sub- rected age of 0.5 With the initial sample size of 176 groups of infants with BPD and multiple risk. An a level of children and an assumed dropout rate at 24 months of 0.05 was used for all tests of significance. All analyses were 10%, the resultant sample size would provide slightly less based on intention to treat. The trial is registered with than 90% power to detect a difference of 0.5 SD.
Data were analyzed using the SPSS 15.0 program (SPSS, Chicago, Illinois). Independent-samples t tests and c2 tests were performed to compare the 2 groups. Multivariate linearregression analyses were used to assess the effect of the inter- The 176 participating infants in this trial until 24-month cor- vention on the MDI, PDI, total-BRS, and CBCL scores, ad- rected age are tabulated in the One of 86 intervention justing for baseline differences. Weeks of gestation, sex, infants did not receive the planned intervention because of cranial ultrasound abnormalities, and oxygen therapy $28 severe psycho-social problems of the mother. According to days were entered as fixed factors considering their potential the intention-to-treat principle, this infant was included in influence on developmental and behavioral outcome. Al- the intervention group. At 24 months, 83 (97%) intervention though the number of low-educated mothers did not differ infants and 78 (89%) of the surviving control infants were between the groups, the factor was added given its potential available for follow-up. Perinatal and demographic charac- influence on infant developmental and behavioral outcome.
teristics of the group that was not available for follow-up Other factors associated with the primary outcomes, differ- did not differ from the group that was assessed at 24 months.
A Neurobehavioral Intervention and Assessment Program in Very Low Birth Weight Infants: Outcome at 24 Months THE JOURNAL OF PEDIATRICS  www.jpeds.com Children who could not complete the developmental assess- Table I. Sociodemographic and perinatal characteristics ment (>5 missing/incomplete items per scale) were excluded from the analyses (Parents of 62 intervention infants (75%) and of 50 control infants (64%) returned the CBCL ).The child’s parents were from various ethnic backgrounds; half of them were born in The Netherlands.
Despite random assignment, more infants in the intervention group were <28 weeks GA than in the control group (21 vs 8; P = .013). In addition, there were more boys in the interven- tion group. More intervention infants had an abnormal cra- nial ultrasound, they had more septic episodes, and were oxygen dependent for a longer period (O2 $28 days and $36 weeks). Also, more intervention infants received indo- methacin or surfactant and were hospitalized for a longer On the mental domain of the BSID-II, 69% intervention vs 63% control children were classified as normal (MDI >85); on the psychomotor domain, 50% intervention vs 45% con- trol children were classified as normal (PDI >85).
The mean (Æ standard deviation [SD]) MDI scores were 91.7 Æ 17 in the intervention group and 90.9 Æ 18 in the con- trol group (P = .72). Mean PDI scores were 87.5 Æ 16 and 83.8 Æ 14, respectively (P = .12). After adjustment for perina- tal and background variables a significant intervention effect was found on the motor scale of 6.4 Æ 2.4 (P = .006). No in- tervention effect was found on the mental scale (2.4 Æ 2.8, P = .38). The effects of factors that independently influenced the primary outcomes and the adjusted means are summa- In total, there were 30 infants with BPD and 21 infants with multiple risk; 12 infants with BPD were included in the mul- tiple risk group. Intervention children with BPD and with multiple risk had higher mental as well as higher motor scores compared with control children with these problems. In the children with BPD the mean Æ SD MDI scores were 88.5 Æ 17.5 in the intervention children vs 73.0 Æ 18 in the control children (P = .05, n = 23 vs7); the mean PDI scores were 81.8 Æ 17.6 in the intervention children vs 61.6 Æ 10.0 in the con- trol children (P = .009, n = 20 vs 7). In children with multiple risk, the mean MDI scores were 86.7 Æ 17.1 in the interven- tion children vs 68.7 Æ 11.0 in the control children (P = .029, n = 15 vs 6); the PDI mean scores were 85.7 Æ 16.6 in the in- tervention children vs 63.8 Æ 14.1 in the control children PMA, postmenstrual age. Numbers are given as number of infants unless otherwise stated.
displays the multivariate linear regression analy- Independent-samples t tests and c2 tests.
*Small for gestational age was defined as <1 SD below the mean for Dutch reference data.
ses, which demonstrates the significant interaction between intervention and BPD and between intervention and multi- zEither breast-fed or expressed milk.
xCerebral hemorrhage (IVH) was defined according to periventricular leukomalacia ple risk. No significant interaction was found between treat- ment and GA <28 and $28 weeks, cranial ultrasoundabnormalities, or low maternal education. Performing theanalyses with only 1 child per family in the case of multiplets,to explore a possible nesting effect, did not change the results.
izing mean Æ SD T-score was 48.0 Æ 8.8 and 45.7 Æ 9.7, re- Table II. Multivariate regression models: Independent spectively, the total problem score was 45.81 Æ 9.09 in effect of factors on MDI, PDI, and BRS of the BSID-II at intervention children and 45.2 Æ 8.9 in control children.
On the internalizing scale, 3 intervention children vs 4 control children scored above the borderline or clinical range; on the externalizing scale, 7 intervention versus vs 6 control children;on the total scale, 4 intervention vs 3 control children. No in- tervention effects were found after adjustment for differences in perinatal characteristics and low maternal education (not Neurological. No differences between the groups were found on neurological outcome measures. At 24 months, 5 intervention infants scored mildly abnormal and 3 interven- tion infants scored abnormal; in the control group, 3 infants scored mildly abnormal and 5 abnormal (P = .24). Between the end of the intervention at 6 months and the assessment at 24 months, significantly fewer intervention infants re- ceived paramedical support (pediatric physical therapy and/or occupational therapy and/or speech therapy) com- pared with control infants: 10 (13%) vs 21 (24%) infants, IBAIP post discharge intervention, supporting VLBW infants until the corrected age of 6 months, improved the child’s mo- tor development at 24-month corrected age. We found a sig- nificantly better score on the psychomotor domain of the BSID-II after adjustment for perinatal factors and the influ- ence of maternal education, which almost reached the pre- planned half standard deviation. The positive intervention Multivariate linear regression analyses: gestation, sex, abnormal ultrasound, O2 $ 28 days, effect on mental and behavioral development that was found and maternal education are included in the model as constant factors; the use of indomethacin, at 6 months was not seen at 24 months. However, in post hoc dopamine, surfactant, septic episodes, and intervention are entered stepwise. Intervention wasincluded as fixed factor in which intervention was excluded from the model.
analyses, we found improved motor as well as improved *The adjusted mean Æ SE MDI scores were 92.5 Æ 2 in the intervention infants and 90 Æ 2 in mental development after IBAIP intervention in subgroups the control infants.
†The adjusted mean Æ SE PDI scores were 88.9 Æ 2 in the intervention infants and 82.4 Æ 2 in of children with BPD and children with multiple risk. Apart from the described outcomes, significantly fewer interven- zThe adjusted mean Æ SE BRS total scores were 57.9 Æ 3 in the intervention infants and55 Æ 4 in the control infants.
tion infants received paramedical services after 6 months,and they were more compliant with follow–up, which under-lines the positive effects of the intervention.
This study demonstrates motor improvement after postdi- Behavioral. At 24 months, 84% of children in both inter- scharge early intervention in VLBW infants at 24 months.
vention and control groups scored in the category normal Benefits on cognitive outcomes from age 2 on were reported test behavior on the BRS; 11% of the intervention, and 13% The Infant Health and Development Program of the control children scored in the category questionable: (IHDP) found a positive cognitive effect in LBW after 3 years 5% vs 3% scored nonoptimal. No statistically significant dif- of frequent home visits, attendance at a child development ferences between the groups were found. The mean total per- center, and parent group meMore recently, the centile score Æ SD was 56.6 Æ 31 in the intervention group APIP reported identical small cognitive gains of a de- and 56.3 Æ 30 in the control group (P = .89). shows velopmental education program or a parent adviser program the effects of factors that independently influenced the out- after supporting VLBW infants and families for 2 years. The comes. No intervention effects were found. Also, no signifi- most vulnerable VLBW infants (<1250 g and those with brain cant differences were found in problem behavior, as injuries) benefited most from the developmental curriculum.
measured with the CBCL. The internalizing mean Æ SD Both programsreported a strong relation between infant T-score on the CBCL was 44.82 Æ 9.4 in the intervention outcomes and social factors, such as the mother’s educational children and 46.2 Æ 10.4 in the control children, the external- level. We found only 1 short postdischarge early intervention A Neurobehavioral Intervention and Assessment Program in Very Low Birth Weight Infants: Outcome at 24 Months THE JOURNAL OF PEDIATRICS  www.jpeds.com Table III. Multivariate regression models: Independent effect of factors, and interaction between BPD1 and intervention,and a Multirisk factor2 and intervention on MDI and PDI of the BSID-II at 24-month corrected age Interaction between multiple risk and intervention 1BPD: oxygen dependency $36 weeks. Multivariate linear regressions analyses: gestation, sex, abnormal cranial ultrasound, BPD, interaction BPD* intervention, low maternal education andintervention are included in the model as contant factors; the use of indomethacin, dopmine, surfactant, septic and septic episodes are entered stepwise.
2Multivariate linear regression analyses: gestation, sex, interaction multirisk* intervention, multirisk, and intervention are included in the model as constant factors; the use of indomethacin,dopamine, surfacant, and septic episodes are entered stepwise.
programcomparable in content to the IBAIP. It included which, in turn, may hinder their environmental explorations.
infants <2000 g and ended at the corrected age of 3 months.
The difference between intervention and control infants was This study applied a modified version of the Mother-Infant stronger in those with multiple risk factors. This shows the Transaction Program (MITP)and found less parenting need to support these often underserved groups with both stress but no significant benefits in infant outcomes at age adverse infant and parent characteristics.Unfortunately, 2. The original version of the MITP reported increasing ben- these post hoc results are based on a small patient group, with efits in cognitive outcome from 3 years on, also preceded by fewer infants with BPD and multiple risk in the control enhanced parenting outcomes (maternal role satisfaction, group. Further studies are warranted to explore these prom- maternal self-confidence and maternal perception of infant ising effects of the IBAIP in high-risk infants.
temperament), which suggests that intervention may have Although better motor performance is expected to be in- a delayed effect on cognitive outcome.
tertwined with improvements in behavioral and cognitive Improved motor outcome in the present study may be ex- development, this was not seen in the outcomes of all plained by the basic elements and timing of IBAIP implemen- our children at 24 months. This may indicate the need of tation. Movement derives from the interactions between the consistent and age-specific preventive interventions after 6 individual, the task, and the environment in which the task is months to further boost the responsiveness of parents to carried out.We hypothesize that supporting both the in- their infant’s development and self-regulation during fant’s individual self-regulatory competencies as well as pro- increasingly complex skills (eg, social-emotional competen- viding the environmental and task activities the infant cies and attention control, language, manipulation, and expected and could handle, enhanced the infant’s informa- tion processing and exploratory abilities. During early in- Given the impact of the IBAIP on motor development at fancy, the sensory-motor system plays a key role in 24 months and its encouraging effect on mental and motor explorations as well as in self-regulation. Hence, these posi- development in the most vulnerable preterm infants, this tive early experiences may have influenced the organization neurobehavioral intervention program may contribute to of the involved brain areas, on which the child could build the early resilience and developmental outcome of VLBW in- after the intervention period.Infants with BPD may have fants after discharge from hospital. We are now studying if profited most from the intervention because they are partic- the effect of the IBAIP sustains until early school age. n ularly vulnerable to stress. Infants with BPD have difficultiesin gaining homeostatic, postural, and state control. These We thank the following pediatricians of all 7 participating Amsterdam problems make them more difficult to handle and harder hospitals for their involvement and cooperation in this study: Rinske to socially engage without physiological compromise, Breur, Hans Budde, Frank van den Dungen, Warda Goudsmit, Marina Keessen, Erik Ree, Janny Samsom (in memoriam), Loekie van 14. Koldewijn K, Wolf MJ, van Wassenaer A, Beelen A, Nollet F, Kok JH. The Sonderen, Louise Spanjerberg, Paolo Valerio, and Bart Wolf.
Infant Behavioral Assessment and Intervention Program to support pre-term infants after hospital discharge: a pilot study. Dev Med Child Neu-rol 2005;47:105-12.
Submitted for publication Feb 25, 2009; last revision received Jul 6, 2009;accepted Sep 2, 2009.
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