Status:
ACTIVE_NOT_RECRUITING
Post-Discharge Growth of Infants Who Received Donor Human Milk Products in the Neonatal Intensive Care Unit (NICU)
Lead Sponsor:
Baylor College of Medicine
Conditions:
Prematurity
Eligibility:
All Genders
Brief Summary
Human milk feeding is associated with great benefits to the health and development of infants, especially in premature infants. Some mothers are unable or unwilling to provide breast milk to their inf...
Detailed Description
An exclusive human milk protein diet in infants less than 1250 grams birth weight has been shown to reduce the rate of necrotizing enterocolitis, a devastating intestinal disease in premature infants,...
Eligibility Criteria
Inclusion
- Premature infants (\<37 weeks gestation) with a birth weight less than or equal to 1250 grams birth weight that received donor human milk products in the NICU during hospitalization.
Exclusion
- Infants with a birth weight greater than 1250 grams.
- Infants transferred from an outside hospital to TCH at greater than one week of age.
- Infants who do not achieve any enteral feeds by 4 weeks of age.
- Infants with major congenital anomalies.
- Infants who die within the first 48 hours of admission to TCH.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2026
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT01483079
Start Date
December 1 2011
End Date
February 1 2026
Last Update
February 25 2025
Active Locations (1)
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1
Texas Children's Hospital
Houston, Texas, United States, 77030