Adolescents Born Preterm; Nurtured Beginnings

NCT00310869 | Unknown DMC

• 1 other identifier: 05-02-021
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preterm Birth

Keywords

Preterm Birth; Prematurity; NIDCAP; Adolescence; Developmental Care; Follow-up; Neurobehavior

Outcome Measures

Primary Outcomes (1)

• Adolescent Cognitive Function

  At time of study

Secondary Outcomes (2)

• Parent socioeconomic status

  From birth to time of study

• Parent cognitive function

  At time of study

Study Arms (1)

E

EXPERIMENTAL

Behavioral: Individualized Developmental Care in the NICU

Interventions

Individualized Developmental Care in the NICU BEHAVIORAL

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.

Also known as: NIDCAP

E

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Related Publications (5)

• 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.

  PMID: 3786036 BACKGROUND

• 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.

  PMID: 8078162 BACKGROUND

• 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.

  PMID: 7478837 BACKGROUND

• 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. doi: 10.1097/00004703-200312000-00001.

  PMID: 14671473 BACKGROUND

• 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. doi: 10.1542/peds.113.4.846.

  PMID: 15060237 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Heidelise Als, PhD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Study Record Dates

• First Submitted: April 3, 2006
• First Posted: April 5, 2006
• Study Start: January 1, 2005
• Primary Completion: June 1, 2019
• Study Completion: December 1, 2019
• Last Updated: June 28, 2017

Record last verified: 2017-06

Locations

US (1)