Post-Discharge Growth of Infants Who Received Donor Human Milk Products in the Neonatal Intensive Care Unit (NICU) (NICU)

Tracking Information
First Submitted Date	November 9, 2011
First Posted Date	December 1, 2011
Last Update Posted Date	May 15, 2018
Study Start Date	December 2011
Estimated Primary Completion Date	September 2018 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: November 29, 2011)	Post-discharge growth and neurodevelopment [ Time Frame: 12-15 months of age ]Per the protocol procedures, growth and development will be assessed at each study visit.; Post-discharge growth and neurodevelopment [ Time Frame: 18-22 months of age ]Per the protocol procedures, growth and development will be assessed at each study visit.; Post-discharge growth and neurodevelopment [ Time Frame: 5 years of age ]Per the protocol procedures, growth and development will be assessed at each study visit.
Original Primary Outcome Measures	Same as current
Change History	Complete list of historical versions of study NCT01483079 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Post-Discharge Growth of Infants Who Received Donor Human Milk Products in the Neonatal Intensive Care Unit (NICU)
Official Title	Evaluation of Post-Discharge Growth and Development of Infants Who Received Donor Human Milk Products in the NICU
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 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.
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, 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: 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.; 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.; 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.
Study Type	Observational
Study Design	Observational Model: Cohort; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	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.
Condition	Prematurity
Intervention	Not Provided
Study Groups/Cohorts	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.
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Enrolling by invitation
Estimated Enrollment; (submitted: November 29, 2011)	80
Original Estimated Enrollment	Same as current
Estimated Study Completion Date	December 2018
Estimated Primary Completion Date	September 2018 (Final data collection date for primary outcome measure)
Eligibility Criteria	Inclusion Criteria: 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 Criteria: 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.
Sex/Gender	Sexes Eligible for Study: All
Ages	Child, Adult, Older Adult
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	United States
Removed Location Countries
Administrative Information
NCT Number	NCT01483079
Other Study ID Numbers	H-29522
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Amy Hair, Baylor College of Medicine
Study Sponsor	Baylor College of Medicine
Collaborators	Not Provided
Investigators	Principal Investigator: Amy B Hair, MD Baylor College of Medicine
PRS Account	Baylor College of Medicine
Verification Date	May 2018