NIDCAP (Newborn Individualized Developmental Care) in Preterm Birth - Clinical Trials Registry

Study Overview

Status

Unknown

Conditions

Preterm Birth

Intervention / Treatment

Behavioral: NIDCAP (Newborn Individualized Developmental Care)

Detailed Description

The protocol aims to demonstrate the effectiveness of an intervention geared to significantly improve functional competence for preterm infants with fetal growth restriction (FGR). Incidence of FGR is estimated to be as high as 5% of the general obstetric population. Preterms with FGR are doubly jeopardized. Aside from much higher mortality rates they also show significantly increased morbidity rates, including significant learning disabilities and school failure (>50%). The intervention's underlying premise holds that it is far more effective to support the immature brain, which is compromised by FGR, to develop optimally before the infant reaches full term rather than to attempt to ameliorate increasingly deviant development after deviance has occurred. The goal of the project is to show the effectiveness of individualized developmental care and intervention, which begins with the FGR preterm infant's admission to the newborn intensive care unit (NICU) and extends to 2 weeks (w) after full term equivalent age or 2w CA (corrected age for prematurity). Intervention in the NICU is considered more advantageous for the infant's later development than delay of intervention until after discharge home. The proposal maintains that the last trimester of gestation is a critical period for brain development, especially when compromised by FGR. In-NICU intervention at this critical brain development time is expected to reduce the infants' hypersensitivity and reactivity while in the NICU, and to lead to reduction of the high incidence of behavioral problems in infancy, which frequently foreshadows later behavioral and learning problems as well as school failure.

The study aims to test three related hypotheses:

Individualized developmental NICU care and intervention will enhance FGR preterm infants' brain development both functionally and structurally.
The in-NICU intervention will improve the parents' understanding of their infant's individuality and equip them to feel more competent as parents.
The intervention itself, while individualized for each infant, will be quantifiable and reliably reproducible.

The study will:

Test the effectiveness of the intervention by assessing brain development and functional adaptation of a high risk preterm population (n=30) with documented intrauterine FGR and born between 28 and 33w gestational age.
Assess the FGR preterm infants' neurodevelopment within one week from birth (baseline) and again at 2w CA (outcome).
Compare the results on the effectiveness of the intervention for the FGR preterm infants to a recently studied cohort of appropriately grown (AGA) preterm infants born at comparable gestational ages, supported with the same intervention and measured in comparable ways.

The primary infant measures proposed will be brain functional (EEG coherence, neurobehavioral functioning) and brain structural assessments (MRI). The goal will be to examine the direct causal connections and correlations among population characteristics, the intervention, and ultimate outcome at 2w CA. The project is expected to deliver comprehensive and substantive results in favor of the developmental NICU intervention for FGR preterm infants as well as for the earlier studied AGA population. The proposed study is expected to demonstrate intervention effectiveness in improving FGR preterm infants' neurodevelopment. It is anticipated that the intervention-based improvement in brain structure and function will set the stage for improvement in later performance, especially in terms of behavioral/emotional adaptation, learning and school achievement, which are all critical for life success.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Massachusetts
  - Boston, Massachusetts, United States, 02115
    - Recruiting
    - Brigham and Women's Hospital
    - Contact:
      
      Heidelise Als, PhD
      
      Phone Number: 617-355-8249
      
      Email: heidelise.als@childrens.harvard.edu
    - Principal Investigator:
      
      Simon Warfield, PhD
  - Boston, Massachusetts, United States, 02115
    - Recruiting
    - Children's Hospital Boston
    - Contact:
      
      Heidelise Als, PhD
      
      Phone Number: 617-355-8249
      
      Email: heidelise.als@childrens.harvard.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 7 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Inborn at Brigham and Women's Hospital, Boston
Gestational age ≥28 and ≤33 weeks
Doppler diagnosed absent or reversed end-diastolic umbilical artery flow velocity
Less than 5th percentile in birthweight and head circumference for gestational age

Exclusion Criteria:

Major chromosomal or congenital anomalies
Major congenital infections
Significant prenatal diagnosed focal brain lesions
Uncontrolled maternal illness
History of smoking, alcoholism, and use of illicit drugs
History of significant maternal deprivation, abuse, or malnutrition
No telephone access and/or insufficient English language facility

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assessment of Preterm Infants' Behavior (APIB) Time Frame: 2 weeks corrected age (2w CA)	2 weeks corrected age (2w CA)
Quantified Electroencephalography (qEEG) Time Frame: 2 weeks Corrected Age (2w CA)	2 weeks Corrected Age (2w CA)
Magnetic Resonance Imaging(MRI) Time Frame: 2 weeks Corrected Age (2w CA)	2 weeks Corrected Age (2w CA)

Secondary Outcome Measures

Outcome Measure	Time Frame
Parent Stress Level Time Frame: 2 weeks Corrected Age (2w CA)	2 weeks Corrected Age (2w CA)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Principal Investigator: Heidelise Als, PhD, Boston Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Anticipated)

December 1, 2008

Study Completion (Anticipated)

June 1, 2009

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria