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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 infant. The use of donor human milk products for very low birth weight infants as an alternative to cow milk has risen dramatically in the past year.
Purpose: To evaluate post-discharge growth and neurodevelopment of infants less than or equal to 1250 grams birth weight receiving an exclusive human milk protein diet.
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, by 50%. New guidelines were introduced in 2009 at Texas Children's Hospital to outline the appropriate use of donor human milk products.
First, infants from a previous study will be identified and recruited for this study. Other potential subjects (infants) will be identified by the GCRC nursing staff at Texas Childrens Hospital upon admission to the neonatal intensive care unit (NICU) (Levels 2 and 3) and communicated to the PI and PIs staff.
This study includes three visits:
If infants were not originally followed in the H-26923 study, additional data will be collected from the infants chart for the hospitalization in the NICU. Data collected will include: anthropometrics at birth and discharge, enteral feeding data and parenteral nutrition throughout admission, nutrition related labs, APGAR scores, medications- lasix, chlorothiazide, dopamine, hydrocortisone and dexamethasone, morbidities such as necrotizing enterocolitis, patent ductus arteriosus, spontaneous intestinal perforation, intraventricular hemorrhage, sepsis, and chronic lung disease.
If infants are re-hospitalized or they receive their primary care from a Texas Childrens Pediatrics Associates Clinic, with the consent of the subjects parents, we would collect information from the chart including: interim anthropometric data, interim medical history, nutrition data and history, and nutrition related labs.
No interventions are part of this protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Former preterm infants | A cohort of infants less than or equal to 1250 grams birth weight that received donor human milk products in the NICU will be recruited and followed. Some infants recruited will be from a previously studied population of very low birth weight infants receiving donor human milk products in the NICU at Texas Children's Hospital. |
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| Measure | Description | Time Frame |
|---|---|---|
| Post-discharge growth and neurodevelopment | Per the protocol procedures, growth and development will be assessed at each study visit. | 12-15 months of age |
| Post-discharge growth and neurodevelopment | Per the protocol procedures, growth and development will be assessed at each study visit. | 18-22 months of age |
| Post-discharge growth and neurodevelopment | Per the protocol procedures, growth and development will be assessed at each study visit. | 5 years of age |
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Inclusion Criteria:
Exclusion Criteria:
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A cohort of infants less than or equal to 1250 grams birth weight that received donor human milk products in the NICU will be recruited and followed. Some infants recruited will be from a previously studied population of very low birth weight infants receiving donor human milk products in the NICU at Texas Children's Hospital.
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| Name | Affiliation | Role |
|---|---|---|
| Amy B Hair, MD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| D000091642 | Urogenital Diseases |