Neurodevelopmental Outcomes of VLBW Infants
Conditions
Keywords
BSID III, Human Milk, Donor Human Milk, Preterm infant, Breastfeeding
Brief summary
Breastfeeding is an important health-promoting behavior. Human milk is the ideal diet for all infants, optimizes intellect, and provides protection against infectious and atopic diseases in childhood as well as decreasing risks for obesity, hypertension and other chronic diseases. Infants with the highest risk of life-long disability, very low birthweight (VLBW) preterm infants, are breastfed at some of the lowest rates in the US. Maternal milk is not always available, and pasteurized donor human milk is an alternative that requires investigation. Whether donor milk conveys health and developmental advantages similar to those bestowed by maternal milk is unknown. By determining the effects of donor milk on health and developmental outcomes when compared to preterm infant formula, the investigators seek to optimize outcomes in this fragile population. The hypothesis of our donor milk research is that a donor human milk diet in non-maternal milk fed VLBW infants is associated with better neurodevelopmental outcome scores at 18-22 months adjusted age than a preterm infant formula diet.
Interventions
DIETARY_SUPPLEMENTDonor Human Milk
Donor Human Milk, obtained from the Mother's Milk of Iowa, a HMBANA milk bank
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Tarah T Colaizy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 24 Months
Healthy volunteers
No
Inclusion criteria
* \<1501 g weight at birth
Exclusion criteria
* chromosomal anomalies * congenital heart disease * congenital disorders known to impair neurodevelopment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive scale score of the Bayley Scales of Infant Development, III | 18 - 22 months' adjusted age | We will administer the BSID III to all subjects at 18-22 mo of age, adjusted for prematurity. We will compare the scores between subjects who received donor human milk to those who received preterm infant formula |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Late Onset sepsis | 4 months | We will compare rates of in-hospital confirmed late onset sepsis in VLBW infants receiving donor human milk and preterm formula |
| length of hospital stay | 4 months | We will compare the length of initial hospital stay between infants who receive donor human milk and those who receive preterm infant formula |
Countries
United States
Outcome results
None listed