Preterm Fetal Growth Restriction and Developmental Care

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00166660
First received: September 9, 2005
Last updated: April 1, 2009
Last verified: March 2009
  Purpose

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).


Condition Intervention Phase
Preterm Birth
Behavioral: NIDCAP (Newborn Individualized Developmental Care)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preterm Fetal Growth Restriction and Developmental Care

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Assessment of Preterm Infants' Behavior (APIB) [ Time Frame: 2 weeks corrected age (2w CA) ] [ Designated as safety issue: No ]
  • Quantified Electroencephalography (qEEG) [ Time Frame: 2 weeks Corrected Age (2w CA) ] [ Designated as safety issue: No ]
  • Magnetic Resonance Imaging(MRI) [ Time Frame: 2 weeks Corrected Age (2w CA) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Parent Stress Level [ Time Frame: 2 weeks Corrected Age (2w CA) ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: July 2004
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: NIDCAP (Newborn Individualized Developmental Care)
    The NIDCAP model aims to create a relationship-based developmentally supportive care environment for the preterm infant and family. The theory proposes that care implementation that takes into account the infants' thresholds of disorganization is most supportive of long term outcome. Specifically, the intervention consisted of weekly neurobehavioral observations and reports of the experimental group infants' behavior with suggestions for parents and staff in ways to support each infant's development. The developmental specialists formally observed each infant's behavior weekly throughout the hospitalization, starting with the phase of the infant's initial stabilization, and then every seven days throughout hospital discharge and to 2wCA.
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:

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

The study will:

  1. 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.
  2. Assess the FGR preterm infants' neurodevelopment within one week from birth (baseline) and again at 2w CA (outcome).
  3. 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.

  Eligibility

Ages Eligible for Study:   28 Weeks to 33 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00166660

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

Publications:
Responsible Party: Heidelise Als, PhD, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00166660     History of Changes
Other Study ID Numbers: R01 HD46855
Study First Received: September 9, 2005
Last Updated: April 1, 2009
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Preterm infants
Developmental Care
NIDCAP
Fetal Growth Restriction
Neurobehavior
APIB
MRI
EEG
Parent Stress

Additional relevant MeSH terms:
Fetal Growth Retardation
Premature Birth
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes
Obstetric Labor, Premature
Obstetric Labor Complications

ClinicalTrials.gov processed this record on April 14, 2014