Adolescents Born Preterm; Nurtured Beginnings - Full Text View

Sponsored by:	Children's Hospital Boston
Information provided by:	Children's Hospital Boston
ClinicalTrials.gov Identifier:	NCT00310869

Purpose

This research study is a long-term follow-up to an earlier study of developmental care. For that study, high risk preterm newborns were randomly assigned to a standard care group, which received the standard care offered in the Newborn Intensive Care Unit (NICU) at the time, or to an experimental group, which received regular behavioral observations to determine if changes in their environment or care were needed. The purpose of the current study is to assess the functioning of these infants again, now that they are adolescents and to compare the groups to determine if the developmental care used in the original study is effective long-term.

Condition	Intervention
Preterm Birth	Behavioral: Individualized Developmental Care in the NICU

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Single Group Assignment, Efficacy Study
Official Title:	Adolescents Born Preterm: Nurtured Beginnings

Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:

Adolescent Cognitive Function [ Time Frame: At time of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Parent socioeconomic status [ Time Frame: From birth to time of study ] [ Designated as safety issue: No ]
Parent cognitive function [ Time Frame: At time of study ] [ Designated as safety issue: No ]

Estimated Enrollment:	70
Study Start Date:	January 2005
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
E: Experimental	Behavioral: Individualized Developmental Care in the NICU Newborn Individualized Developmental Care and Assessment Program (NIDCAP) utilizes close observation of each infant's thresholds of moving from organization to disorganization and stress, as exhibited by the infant's behavior. Care and environment are then continuously and dynamically adjusted to increase the infant's self-regulation and organization and decrease the infant's stress. This individualized model of NICU care provides an opportunity to investigate the modifiability of very early born infants' brain function and structure and the possibility of reducing or altogether eliminating the disruption and disturbance of fetal brain development in the NICU.

Arms

Assigned Interventions

E: Experimental

Behavioral: Individualized Developmental Care in the NICU

Newborn Individualized Developmental Care and Assessment Program (NIDCAP) utilizes close observation of each infant's thresholds of moving from organization to disorganization and stress, as exhibited by the infant's behavior. Care and environment are then continuously and dynamically adjusted to increase the infant's self-regulation and organization and decrease the infant's stress. This individualized model of NICU care provides an opportunity to investigate the modifiability of very early born infants' brain function and structure and the possibility of reducing or altogether eliminating the disruption and disturbance of fetal brain development in the NICU.

Detailed Description:

The study will test continued long-term intervention effectiveness into adolescence of very early born US preterm infants, who participated in a randomized Newborn Individualized Developmental Care and Assessment Program (NIDCAP) trial, conducted by the principal investigator, while the infants were cared for in the NICU for the first three months after their very premature births. All adolescents to be studied participated as newborns and were assigned either to control care (standard NICU care available at the time), or to experimental care (NIDCAP developmental care, with weekly bedside observations and with daily NIDCAP developmental specialist support to parents and staff), from NICU admission until 2 weeks (w) after expected full-term due date ('corrected' age [CA]).

The strongly brain-based theory underlying the approach to earliest intervention described here has been tested in several experimental studies, which are designed to investigate the effects of planned purposeful modification of experience for very early born infants, who spend the third trimester of gestation in the NICU. NIDCAP is based on an approach which utilizes close observation of each infant's thresholds of moving from organization to disorganization and stress, as exhibited by the infant's behavior. Care and environment are then continuously dynamically adjusted, with the goal to increase the infant's self-regulation and organization and decrease the infant's stress. This individualized model of NICU care provides an opportunity to investigate the modifiability of very early born infants' brain function and structure and the possibility of reducing or altogether eliminating the disruption and disturbance of fetal brain development in the NICU. The randomized scientific trials to date, conducted by the PI and by independent investigators at other settings after formal training show consistent significant neurobehavioral and neurophysiological improvements for the experimental groups across sites and studies.

All the adolescents to be studied were evaluated comprehensively at 2wCA and 9 months (m) CA in terms of not only the commonly measured demographic, medical background and severity of illness variables, but more importantly in terms of comprehensive neurobehavioral and EEG outcome measures, analogues of later developmental competence and disability.

The design of the current study of adolescents is that of a randomized controlled trial (RCT) with two parallel groups (control and experimental), with the question of the independent variable 'group effect' on two dependent measures (adolescent physical growth and cognitive development). In addition to group status, the contribution of four additional independent measures on outcome will also be evaluated: Parent socioeconomic status, parent cognitive function, adolescent physical function and adolescent psychosocial function. The outcome examiners will be blind to subject group status throughout. The design assures a true experimental test of the NICU intervention effects in adolescence.

The significance and importance of the study lays in the unique opportunity to evaluate comprehensively in adolescents the long-term neurodevelopment, learning and adaptive outcomes due to developmental care intervention received in the earliest stage of development. This will be the first study to test the long-term effectiveness of modification of experience in the NICU in a brain-protective, learning-enhancing model for very high-risk, very early-born preterm infants. The importance of the study lies in its potential to contribute significantly to the understanding of preterm brain development in relationship to long-term mental and adaptive functional outcomes in adolescence for the highly jeopardized and growing group of very preterm children. The results are expected to be of key importance in decision and policy development for the evidence-based targeting of sparse special education resources.

Eligibility

Ages Eligible for Study:	14 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria (when recruited as newborns):

Gestational age at birth ≤ 28 weeks
Birth weight ≤ 1250 grams
In need of mechanical ventilation for at least 24 of the first 48 hours
Singleton
Born at the study hospital
Free of known genetic or acquired infections or abnormalities
Mother living in the vicinity of the study hospital
Mother comfortable with English
Mother free of major physical and mental illnesses

Exclusion Criteria (when recruited as newborns):

Gestational age at birth > 28 weeks
Birth weight > 1250 grams
No mechanical ventilation for the first 48 hours
Multiple (twin, triplet)
Not born at the study hospital
Genetic or acquired infections or abnormalities
Mother lived outside the vicinity of the study hospital
Mother was not comfortable with English
Mother had major physical and/or mental illnesses

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00310869

Contacts

Contact: Heidelise Als, PhD

617-355-8249

Heidelise.Als@childrens.harvard.edu

Locations

United States, Massachusetts
Children's Hospital Boston	Recruiting
Boston, Massachusetts, United States, 02115
Sub-Investigator: Gloria B. McAnulty, PhD
Sub-Investigator: Frank Duffy, MD
Sub-Investigator: Jane Bernstein, PhD

Sponsors and Collaborators

Children's Hospital Boston

Investigators

Principal Investigator:

Heidelise Als, PhD

Children's Hospital Boston

More Information

Publications:

Als H, Lawhon G, Brown E, Gibes R, Duffy FH, McAnulty G, Blickman JG. Individualized behavioral and environmental care for the very low birth weight preterm infant at high risk for bronchopulmonary dysplasia: neonatal intensive care unit and developmental outcome. Pediatrics. 1986 Dec;78(6):1123-32.

Als H, Lawhon G, Duffy FH, McAnulty GB, Gibes-Grossman R, Blickman JG. Individualized developmental care for the very low-birth-weight preterm infant. Medical and neurofunctional effects. JAMA. 1994 Sep 21;272(11):853-8.

Buehler DM, Als H, Duffy FH, McAnulty GB, Liederman J. Effectiveness of individualized developmental care for low-risk preterm infants: behavioral and electrophysiologic evidence. Pediatrics. 1995 Nov;96(5 Pt 1):923-32.

Als H, Gilkerson L, Duffy FH, McAnulty GB, Buehler DM, Vandenberg K, Sweet N, Sell E, Parad RB, Ringer SA, Butler SC, Blickman JG, Jones KJ. A three-center, randomized, controlled trial of individualized developmental care for very low birth weight preterm infants: medical, neurodevelopmental, parenting, and caregiving effects. J Dev Behav Pediatr. 2003 Dec;24(6):399-408. Erratum in: J Dev Behav Pediatr. 2004 Jun;25(3):224-5.

Als H, Duffy FH, McAnulty GB, Rivkin MJ, Vajapeyam S, Mulkern RV, Warfield SK, Huppi PS, Butler SC, Conneman N, Fischer C, Eichenwald EC. Early experience alters brain function and structure. Pediatrics. 2004 Apr;113(4):846-57.

Responsible Party:	Children's Hospital Corporation ( Heidelise Als, PhD )
Study ID Numbers:	05-02-021
Study First Received:	April 3, 2006
Last Updated:	May 15, 2008
ClinicalTrials.gov Identifier:	NCT00310869
Health Authority:	United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:

Preterm Birth
Prematurity
NIDCAP
Adolescence

Developmental Care
Follow-up
Neurobehavior

Study placed in the following topic categories:

Pregnancy Complications
Obstetric Labor, Premature
Obstetric Labor Complications
Premature Birth

ClinicalTrials.gov processed this record on January 15, 2009