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Intrauterine Growth RetardationNCT00914108

Severe Intrauterine Growth Retardation: Developmental Newborn Intensive Care Unit (NICU) Care

A study testing Newborn Individualized Developmental Care in people with Intrauterine Growth Retardation and Prematurity, run by Boston Children's Hospital at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the study is to learn more about the development of small for gestational age (SGA) preterm infants and whether focusing on the infant's behavior has a positive effect on outcome. Read more about this study

Who is it for?
Ages Up to 36 weeks
Conditions the study is for
Intrauterine Growth Retardation, Prematurity
What is being tested?
Newborn Individualized Developmental Care
How many people
30 participants
Where
2 sitesUnited States
Study dates
Oct 1996to Jul 2002
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 36 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Inborn at the Brigham and Women's Hospital
  • Gestational age < 36 weeks
  • Birthweight < 5th percentile
  • Head circumference at birth < 5th percentile

Who cannot join

  • Presence of major chromosomal or congenital anomalies (Down's, Turner's, Klinefelter's Syndrome, etc.)
  • Presence of major congenital infections (HIV, TORCH)
  • Presence of significant prenatal focal brain lesions (intrauterine infarcts; cystic changes, etc.)
  • Presence of major maternal illness (uncontrolled diabetes, active seizure disorder requiring medication during pregnancy, renal transplant), mental and/or emotional impairment (including heroin addiction and documented alcoholism)

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Children's Hospital Boston

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: Family-Centered Neuropsychoeducational In-NICU Intervention for Preterm Infants With Severe Intrauterine Growth Retardation and for Their Families

The purpose of the study is to learn more about the development of small for gestational age (SGA) preterm infants and whether focusing on the infant's behavior has a positive effect on outcome. The study hypotheses state: 1) High risk severely SGA preterm infants will profit from detailed neuropsychological assessment, psychoeducational recommendations and practical guidance for caregiving, as well as formal educational and emotional support for the family and the professional care team. 2) Neuropsychological education and guidance for community-based early intervention providers caring for SGA preterm infants after their discharge is effective in promoting improved outcome.

Read the detailed description

The preterm infant who is not only born early but also did not grow well in the womb is at double jeopardy for developmental disabilities. The literature indicates that the fetus who has not gained weight properly nor is showing expected head growth in the womb [symmetrical intrauterine growth retardation (IUGR) or small for gestational age (SGA) status] will not only require significantly longer stays in the newborn intensive care unit (NICU) and grow more poorly than the appropriately grown prematurely born infant, but will also show significant disabilities later on in terms of fine and gross motor skills, cognitive function activity, language abilities, abstract reasoning, concentration, attention, mood and temperament. IUGR exerts an independent adverse effect on the developmental outcome of preterm infants.

Given the importance of the last 4 months of gestation and the first 2 years post term for brain growth and development, and given the relationship between cerebral development and behavior which is a two-way street and a dynamic feedback system, the particular vulnerability of SGA children to environmental factors indicates that there are grounds for the hypothesis that appropriate support and intervention for severely SGA preterm infants and their families might ameliorate dysfunction.

The general purpose of the proposed project is to develop and test a model of ameliorative neuropsychoeducational intervention in the NICU in support of the developmental outcome of severely SGA preterm infants and their families. The specific hypotheses to be tested are as follows:

  1. High risk severely SGA preterm infants cared for in the NICU with the support of a neuropsychoeducational model of intervention will show:
  2. At 2 weeks post term, more well-regulated autonomic, motor, state organizational and attentional functioning
  3. At 9 and 24 months post term:
  • More well-regulated autonomic and visceral functioning with less colic and improved eating patterns and weight gain
  • More well-regulated motor system performance
  • More well-regulated state organization, including sleep and awake organization
  • More well-regulated cognitive and attentional functioning in various domains, including visual-motor integration, spatial planning, attentional planning, expressive and receptive language function, abstract verbal reasoning, short term memory and continuous performance regulation
  • More well-regulated executive function capacities
  • More well-regulated affective emotional functioning
  1. Parents whose infants receive the support of a neuropsychoeducational model of care will show:
  2. At 2 weeks, 9 and 24 months post term, enhanced appreciation of their infant as an individual
  3. At 9 and 24 months post term, more sensitively attuned input in support of their child's functioning, more competent parenting strategies, and a greater sense of effectiveness in parenting the child.

The population will consist of severely small for gestational age preterm infants admitted to the NICU and randomly assigned to a control and experimental group.

Effectiveness of the experimental treatment for the experimental group will be tested at three systematic outcome points in various domains. The domains assessed include (1) medical outcome; (2) neurobehavioral outcome; (3) neuroelectrophysiological outcome; and (4) family outcome. The outcome points for infant and family are 2 weeks, 9 and 24 months after expected due date.

The study is expected to demonstrate intervention effectiveness in improving IUGR preterm infants' neurodevelopment. It is anticipated that the results will set the stage for a model of caregiving and intervention that lives up to the mandate that every child is entitled to an environment, care and education appropriate to his or her specific needs. The model can then be used in other nurseries to provide improved outcome for preterm populations.

Being tested
Newborn Individualized Developmental Care
Keywords
Preterm Infants, Developmental Care, NIDCAP, Intrauterine Growth Restriction, APIB, EEG, Neurobehavior
Medical subject headings
Fetal Growth Retardation, Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Newborn Individualized Developmental CareBehavioural

    Also called NIDCAP

    The developmental care 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 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 observed each infant's behavior throughout hospitalization and to 2 weeks corrected age and formulated descriptive neurobehavioral reports with suggestions to structure caregiving procedures adapted to the infant's sleep/wake cycle and in support of the infant's well-regulated behavioral balance. Parents were supported to care for their infant, encouraged to nurse and hold their infant skin-to-skin, and to cradle them during stressful procedures.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evidence of improved neurodevelopmental and neurophysiological outcome as assessed with: Assessment of Preterm Infants' Behavior (APIB) and electrophysiological (EEG) assessment

    Measured: At 2 weeks , 9 months and 24 months corrected age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2009 (estimated)
  2. Study startOct 1996
  3. Primary completionJul 2000
  4. Study completionJul 2002

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00914108
Sponsor's protocol ID
X03-10-072R
Status last verified
Jun 2009
First submitted
3 Jun 2009
Last updated
11 Aug 2026
Results posted
No
Data monitoring committee
No

Publications

  • McAnulty G, Duffy FH, Kosta S, Weisenfeld NI, Warfield SK, Butler SC, Alidoost M, Bernstein JH, Robertson R, Zurakowski D, Als H. School-age effects of the newborn individualized developmental care and assessment program for preterm infants with intrauterine growth restriction: preliminary findings. BMC Pediatr. 2013 Feb 19;13:25. doi: 10.1186/1471-2431-13-25.

    PubMed 23421857
  • Als H, Duffy FH, McAnulty G, Butler SC, Lightbody L, Kosta S, Weisenfeld NI, Robertson R, Parad RB, Ringer SA, Blickman JG, Zurakowski D, Warfield SK. NIDCAP improves brain function and structure in preterm infants with severe intrauterine growth restriction. J Perinatol. 2012 Oct;32(10):797-803. doi: 10.1038/jp.2011.201. Epub 2012 Feb 2.

    PubMed 22301525
  • Als H, Duffy FH, McAnulty GB, Fischer CB, Kosta S, Butler SC, Parad RB, Blickman JG, Zurakowski D, Ringer SA. Is the Newborn Individualized Developmental Care and Assessment Program (NIDCAP) effective for preterm infants with intrauterine growth restriction? J Perinatol. 2011 Feb;31(2):130-6. doi: 10.1038/jp.2010.81. Epub 2010 Jul 22.

    PubMed 20651694

Questions about this trial

What is this clinical trial studying?

A study testing Newborn Individualized Developmental Care in people with Intrauterine Growth Retardation and Prematurity, run by Boston Children's Hospital at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evidence of improved neurodevelopmental and neurophysiological outcome as assessed with: Assessment of Preterm Infants' Behavior (APIB) and electrophysiological (EEG) assessment (time frame: At 2 weeks , 9 months and 24 months corrected age). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00914108, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.

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