Effect of Extensively Hydrolyzed Liquid Human Milk Fortifier on Growth and Tolerance in Moderately Premature Infants

Study Overview
=================
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.

Official Title
-----------------
Effect of Extensively Hydrolyzed Liquid Human Milk Fortifier on Growth and Tolerance in Moderately Premature Infants

Conditions
-----------------
Complication of Prematurity

Intervention / Treatment
-----------------
* Dietary Supplement: Powder HMF
* Dietary Supplement: Liquid HMF


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 28 Weeks
Maximum Age: 34 Weeks

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Powder HMF<br>Once patient has reached 80ml/kg/day of enteral feedings, 1 pack of powder HMF will be added to 50 ml of human or donor breast milk, then increased to a maximum of 2 packs for 50 ml following the unit feeding advancement protocol and this will be continued up until 48 hours prior to discharge. | Dietary Supplement: Powder HMF<br>* powder human milk fortifier<br>|
| Active Comparator: Liquid HMF<br>Once patient has reached 80ml/kg/day of enteral feedings, researchers will add 1 packet (5 ml) of liquid HMF to 50 ml of human or donor breast milk, then increase to 2 packs to 50 ml following the unit feeding protocol and this will be continued up until 48 hours prior to discharge. | Dietary Supplement: Liquid HMF<br>* Liquid human milk fortifier<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative weight gain | Weight gain of baby during the course of the study | Baseline to 36 Weeks post-conceptional age or Study Day 28, whichever is earlier | 
| Change in weight | Weight gain of baby week-to-week, during the course of the study | Baseline to 36 Weeks post-conceptional age or Study Day 28, whichever is earlier | 
| Linear length | change in length week-to-week during the course of the study | Baseline to 36 Weeks post-conceptional age or Study Day 28, whichever is earlier | 
| Head growth | Change in head measurements week-to-week during the course of the study | Baseline to 36 Weeks post-conceptional age or Study Day 28, whichever is earlier | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutrition biomarkers | Measurements of a baby's Ca, P, Mg, Alkaline Phosphatase and Prealbumin will be taken | Baseline to 36 Weeks post-conceptional age or Study Day 28, whichever is earlier | 
| Tolerance to enteral feeds | number of significant residuals, number of times feeds were held, NEC | Baseline to 36 Weeks post-conceptional age or Study Day 28, whichever is earlier | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prematurity, growth, nutrition, human milk fortifier