View Clinical Trial (Medical Research Study)
Preterm Fetal Growth Restriction and Developmental Care
| City: |
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Boston |
| State: |
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Massachusetts |
| Zip Code: |
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02115 |
| Conditions: |
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Preterm Birth |
| Purpose: |
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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).
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT00166660 |
| Primary Contact: |
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Principal Investigator
Heidelise Als, PhD
Children's Hospital Boston
Heidelise Als, PhD
Phone: 617-355-8249
Email: heidelise.Als@childrens.harvard.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Boston, Massachusetts 02115
United States
Heidelise Als, PhD
Phone: 617-355-8249
Email: heidelise.als@childrens.harvard.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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