Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT01483079 |
| Other study ID # |
H-29522 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 2011 |
| Est. completion date |
December 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Baylor College of Medicine |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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 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.
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, 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:
1. Outpatient visit at 12 to 15 months corrected gestational age- first outpatient visit to
obtain baseline anthropometric data, interim medical history, demographic and
socioeconomic information, and nutrition history of the child since discharge (formula,
human milk, vitamins, and medications), and check hemoglobin and ferritin. Parents will
bring their childs labs from the pediatrician or give permission for records to be
accessed in Epic if they receive care from Texas Childrens Pediatric Associates. If
records are obtained, labs will not be drawn at this visit. Some of the historical
information may be obtained via telephone prior to the outpatient visit.
2. Outpatient visit at 18 to 22 months corrected gestational age- second outpatient visit
for collection of anthropometric data, interim medical history, demographic and
socioeconomic information, nutrition history, routine Neurodevelopmental Evaluation as
part of standard follow-up for extremely low birth weight infants (The Bayley Scales of
Infant Development II) administered by certified testers (trained professional), and
whole body dual energy x-ray absorptiometry (DXA) will be performed. Some of the
historical information may be obtained via telephone prior to the outpatient visit. We
will also obtain the height and weight of mom and dad at this visit.
3. Outpatient visit at 5 years of age- third outpatient visit for collection of
anthropometric data, interim medical history, demographic and socioeconomic information,
nutrition history and developmental evaluation as routine for a school age child. Some
of the historical information may be obtained via telephone prior to the outpatient
visit.
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.
