Clinical trial NCT04294368: Targeted Fortification of Donor Breast Milk in Preterm Infants
Official title: Targeted Fortification of Donor Breast Milk in Preterm Infants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prematurity; Extreme
Failure to Thrive in Newborn
Growth Retardation
Growth Failure
Infant Nutrition Disorders
Keywords: Human Milk Analyzer
Miris
Target Fortification
Targeted Fortification
Donor Breast Milk
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2020-03-04
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Control group to receive standard fortification of donor breast milk. Experimental group to receive targeted fortification of donor breast milk.
Primary purpose: PREVENTION

Brief summary: This study is a randomized controlled trial comparing standard fortification of donor breast milk to targeted fortification of donor breast milk in preterm infants. The purpose of the study is to determine if there is a benefit to target fortifying donor breast milk in the preterm population. The investigators hypothesize that infants receiving targeted fortification of donor breast milk will have improved growth compared to infants receiving standard fortification of donor breast milk.

Detailed description: Breast milk is the best food for premature infants due to its ability to protect infants from necrotizing enterocolitis (NEC) and late onset sepsis. When a premature infant's mother's own milk supply is not enough to provide all the milk that her premature infant needs, donated breast milk is the next best option. One of the downsides of donor breast milk is that it often does not contain as much nutrition for the developing infant compared to the milk of a mother of a premature infant. This means a higher likelihood for poor growth in infant receiving mostly donor breast milk compared to mom's own milk. Due to an inability to easily measure the nutritional content of donor breast milk, standard practice has been to assume that the milk has a certain amount of fat, carbohydrates, and protein. Based on these assumptions, a set amount of additional nutritional fortifier is added to both donor and mom's own breast milk prior to it being given to the infant. Studies show that there is often less nutrition in the donor breast milk to start with than assumed. Technology is now available which uses a small volume sample to measure fat, protein, and carbohydrates in human milk, and hence, calculate the calories in the milk. Using this technology, in this study, the investigators will customize the fortification of donor breast milk by first measuring what is in the milk and then adding any additional fortification that is needed to reach the recommended goals for fat, protein, and carbohydrates. The investigators hypothesize that infants receiving this customized milk, so-called "target" fortified donor breast milk, will have better growth than infants receiving the standard amount of fortification added to their donor breast milk.

The study design involves measurement of macronutrient and calorie content of donor breast milk using a point-of-care human milk analyzer (Miris, AB). The individual macronutrient (protein, fat, and carbohydrate) concentrations will be targeted in the intervention group such that the infant will receive protein of 4 g/kg/day, fat of 6.6 g/kg/day, and carbohydrates of 11.6-13.2 g/kg/day. Fortification will be added in a step-wise fashion daily over a 3-4 day period starting when the infant reaches about 80 ml/kg/day in feeding volume. Fortifiers that may be used in this study include: Abbott Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid, Abbott Liquid Protein, Nestle Microlipid, and Medica Nutrition SolCarb. Participants in the control arm will receive donor milk that is fortified in the standard fashion at this institution; that is, 4 packets of Human Milk Fortifier will be added to 100 ml of donor breast milk. Additional fortification such as liquid protein or microlipid may be added to the donor milk and mom's own milk in response to poor growth for participants in both groups, as is standard of care in this Neonatal Intensive Care Unit (NICU). Patients in both experimental and control groups will always receive mom's own milk first when it is available. Mom's own milk will not be analyzed and will always be fortified in the standard fashion for both groups. The participants will be studied until they reach 34 weeks corrected gestational age.

Eligibility criteria: Inclusion Criteria:

* Premature infants born \</= 30 weeks gestational age
* Birth Weight \</= 1500 grams

Exclusion Criteria:

* Parents do no consent to donor milk
* Confounders for poor growth such as congenital heart disease, GI diagnoses such as gastroschisis and omphalocele, and or major congenital anomalies
* Grade III or IV intraventricular hemorrhage diagnoses prior to randomization
* Small for gestational age (\<3% on Fenton Growth Curve)
* Failure to initiate fortified feeds prior to 3 weeks of life
* Diagnosis of necrotizing entercolitis prior to randomization
* Diagnosis of early onset sepsis confirmed with positive culture

Primary outcomes:
measure: Change in weight
timeFrame: Up to 11 weeks
measure: Change in length
timeFrame: Up to 11 weeks
measure: Head circumference
timeFrame: Up to 11 weeks
Secondary outcomes:
measure: Total Number of Days of Length of Stay in NICU
timeFrame: Up to 1 year
measure: Rate of Mortality
timeFrame: Up to one year
measure: Number of Feeding Intolerance Events
timeFrame: Up to 34 weeks corrected gestational age
measure: Number of Necrotizing Enterocolitis Events
timeFrame: Up to 1 year of age
measure: Incidence of Bronchopulmonary dysplasia
timeFrame: Up to 1 year of age
measure: Incidence of Retinopathy of prematurity
timeFrame: Up to 1 year of age
measure: Percentage of Feeds with Donor Milk and Mother's Milk
timeFrame: Up to 34 weeks corrected gestational age
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center/ New York - Presbyterian
state: New York
Study officials:
affiliation: Columbia University
name: Marianne Garland, MD
role: PRINCIPAL_INVESTIGATOR
References:
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