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Adolescents Born Preterm; Nurtured Beginnings

NCT00310869 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2017-06-28

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Heidelise Als, PhD · Boston Children's Hospital

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2019-06-30
Completion
2019-12-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00310869 on ClinicalTrials.gov