Complication of Prematurity
Conditions
Keywords
prematurity, growth, nutrition, human milk fortifier
Brief summary
The purpose of this study is for the researchers to examine the safety and efficacy of liquid human milk fortifier (HMF) in moderately preterm infants compared to powdered human milk fortifier.
Detailed description
This is a prospective, randomize, double-blinded study in preterm infants born between 28-34 weeks gestation admitted to the NICU at the University of Kansas Hospital. After obtaining informed consent, babies will be randomized to either liquid or powdered HMF using opaque, sealed envelopes with preassigned randomization. The feeding protocol as established in the KU NICU will be followed, beginning with initiation of trophic feeds, and advancement of enteral feeds depending on the gestational age and preceding illnesses. Once infants reach 80ml/kg/day of enteral feeds, human milk will be fortified to 22 kilocalories by adding either liquid or powdered fortifier. The beginning of the study(Study day 1) will be defined as reaching and tolerating 100ml/kg/day of 24 kilocalorie human milk fortified with either liquid or powdered fortifier. Enteral feeds will be advanced per unit protocol until they reach 150-160ml/kg/day and 110-120 kcal/kg/day. the volume of feeds will be adjusted based on the documented weight to provide energy and protein requirements as recommended by the ESPGHAN guidelines. Babies will be followed up until the time of NICU discharge.
Interventions
DIETARY_SUPPLEMENTPowder HMF
powder human milk fortifier
DIETARY_SUPPLEMENTLiquid HMF
Liquid human milk fortifier
Sponsors
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
28 Weeks to 34 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Inborn preterm infants born between 28 0/7 and 34 0/7 weeks gestation and fed either mother's own milk or donor human milk
Exclusion criteria
* Newborn infants \<28 weeks and \>34 weeks gestation, those with life threatening illness, congenital and chromosomal anomalies, gastrointestinal anomalies or necrotizing enterocolitis and fed premature formula
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative weight gain | Baseline to 36 Weeks post-conceptional age or Study Day 28, whichever is earlier | Weight gain of baby during the course of the study |
| Change in weight | Baseline to 36 Weeks post-conceptional age or Study Day 28, whichever is earlier | Weight gain of baby week-to-week, during the course of the study |
| Linear length | Baseline to 36 Weeks post-conceptional age or Study Day 28, whichever is earlier | change in length week-to-week during the course of the study |
| Head growth | Baseline to 36 Weeks post-conceptional age or Study Day 28, whichever is earlier | Change in head measurements week-to-week during the course of the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nutrition biomarkers | Baseline to 36 Weeks post-conceptional age or Study Day 28, whichever is earlier | Measurements of a baby's Ca, P, Mg, Alkaline Phosphatase and Prealbumin will be taken |
| Tolerance to enteral feeds | Baseline to 36 Weeks post-conceptional age or Study Day 28, whichever is earlier | number of significant residuals, number of times feeds were held, NEC |
Countries
United States
Outcome results
None listed