Evaluating feeding practices for very low birth weight infants in the NICU
Quality Improvement Project - Evaluation of Current Standard of Care for Feeding Practices With Donor Human Milk Products in the NICU
This study looks at how very low birth weight infants in the NICU are fed donor human milk to see if it helps them grow well and stay healthy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 1 Day and up |
| Sex | All |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT01204983 on ClinicalTrials.gov |
What this trial studies
This project assesses the current nutritional management practices for very low birth weight infants receiving donor human milk in the NICU at Texas Children's Hospital. It involves collecting data on infants who weigh 1250 grams or less at birth, starting from their first enteral feeding. The study aims to monitor growth parameters and electrolyte levels to identify any potential nutritional issues associated with donor human milk. The project does not involve randomization or control groups, focusing instead on observational data collection throughout the infants' hospitalization.
Who should consider this trial
Good fit: Ideal candidates for this project are premature infants born at less than 37 weeks gestation with a birth weight of 1250 grams or less.
Not a fit: Patients who may not benefit from this project include those with a birth weight greater than 1250 grams or those with major congenital anomalies.
Why it matters
Potential benefit: If successful, this project could improve the nutritional management of very low birth weight infants, potentially reducing the risk of electrolyte imbalances and associated health complications.
How similar studies have performed: While this approach is observational and specific to donor human milk, similar studies have shown the benefits of human milk in neonatal care, suggesting potential for positive outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Premature infants (\<37 weeks gestation) with a birth weight less than or equal to 1250 grams. Exclusion Criteria: * Infants with a birth weight greater than 1250 grams * Infants transferred from an outside hospital to TCH at greater than 21 days of age * Infants who do not achieve any enteral feeds by 4 weeks of age * Infants with major congenital anomalies
Where this trial is running
Houston, Texas
- Baylor College of Medicine / Texas Children's Hospital — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Amy Hair, MD — Baylor College of Medicine
- Study coordinator: Amy B Hair
- Email: abhair@texaschildrens.org
- Phone: 7138767323
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.