Status:
RECRUITING
Early Childhood Obesity Programming by Intrauterine Growth Restriction
Lead Sponsor:
Montefiore Medical Center
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Icahn School of Medicine at Mount Sinai
Conditions:
Childhood Obesity
Epigenetics
Eligibility:
All Genders
1-24 years
Brief Summary
The molecular mechanisms underlying developmental programming of childhood obesity remain poorly understood. Here, the investigators address major questions about early childhood obesity programming b...
Detailed Description
Epidemiological studies of multiple cohorts suggest an increased risk for obesity, cardiovascular disease-related death and type 2 diabetes in low birth weight infants. However, the molecular mechanis...
Eligibility Criteria
Inclusion
- Mother-infant pairs will be recruited for this study.
- Healthy singleton term intrauterine growth restricted (IUGR) and appropriate for gestational age (AGA) infants whose mothers are followed by the Obstetric Department of Montefiore Medical Center and who deliver at the Weiler Division of Montefiore Medical Center. Infants will be classified as IUGR if birth weight is \<10th percentile for gestational age and gender based on World Health Organization (WHO) growth curves. Infants will be classified as AGA if birth weight percentile is \>10th and \<90th percentile
- Reproductive age women, healthy enough to achieve pregnancy
- Deliver a single healthy live term infant at ≥37 weeks' gestational age (GA)
- All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Exclusion
- Multiple gestation
- Maternal depression
- Maternal renal disease
- History of maternal smoking in the 2nd and 3rd trimester of pregnancy
- Maternal gestational diabetes / Type 2 Diabetes (T2D)
- Preterm birth (less than 37 weeks' gestation)
- Known chromosomal or congenital anomaly
- Infants in extremis
- Low Apgar scores (Apgar score \<7 at 5 minutes of age)
- Known congenital bacterial or non-bacterial infections
- Known inborn errors of metabolism
Key Trial Info
Start Date :
September 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT03402139
Start Date
September 1 2018
End Date
March 1 2028
Last Update
September 15 2025
Active Locations (1)
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1
Jack D. Weiler Hospital
The Bronx, New York, United States, 10461