Clinical trial NCT04025021: Targeted Breast Milk Fortification for Very Low Birth Weight Infants in the NICU
Official title: Targeted Fortification of Human Breast Milk and Adjustment of TPN for Very Low Birth Weight Infants to Optimize Growth and Nutrition Using the Miris Mid-infrared Human Milk Analyzer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Human Milk
Neonate
Breast Milk
Keywords: Targeted Fortification
Human Milk Analysis
Neonatal Nutrition
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
First posted: 2019-07-18
Enrollment: 3
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will be a randomized control trial with 2 arms: control group (standard fortification) or intervention group (targeted fortification) in a 1:1 allocation ratio. Allocation group will be stratified to four groups according to birth weight: \<750g, 751-1000g, 1001-1250g, 1251-1500g. This stratification is based upon our NICU feeding guideline, and will ensure that enrolled infants will receive comparable nutrition progression (e.g. NPO (nil per os) days, days of trophic feeds) throughout the study period. The allocation will be concealed in a sequentially numbered, opaque, sealed envelope, that will be opened after consent is obtained.
Primary purpose: TREATMENT

Brief summary: This study evaluates the effectiveness of individualized human milk fortification for very low birth weight (\<1500 g) babies in the NICU (Neonatal Intensive Care Unit) to optimize their growth. Breast milk analysis will occur on a weekly basis using the Miris Human Milk Analyzer. In the Control group, participants will receive standard TPN (total parenteral nutrition) and lipids and breast milk fortification according to MetroHealth's NICU guidelines. The Intervention group will receive TPN and lipids optimized depending on the results of breast milk analysis, followed by additional individualized fortification using additional microlipids and/or liquid protein to achieve the goal of 4g protein/kg/day and 100-130 kcal/kg/day.

Detailed description: Human milk has a variety of benefits for neonates, especially premature neonates, including a decreased risk of for necrotizing enterocolitis, sudden infant death syndrome (SIDS), respiratory syncytial virus (RSV) bronchiolitis, respiratory infections, and many other childhood conditions. There is variability in macronutrient and caloric content of breast milk between mothers, making it difficult to accurately quantify the nutritional content the breast milk is providing. The protein content varies by postnatal age, and the fat content varies temporally during a feed. Currently calculations use a standard value for caloric density and macronutrient content of breast milk, which is a reported average, but not necessarily specific to each individual mother. Human milk analysis has been used to address this variability. The Miris Human Milk Analyzer (HMA) is a mid-infrared analyzer and has been evaluated in many studies. It measures the macronutrient content of breast milk, providing values for protein, fat, carbohydrates, and calculated calories. By having this information available, the fortification added to breast milk can be tailored specifically to each mother's breast milk composition to meet each neonate's nutritional needs, and optimize growth.This will be a prospective randomized control study of preterm infants less than 1500 grams \[very low birth weight (VLBW)\] receiving human milk (maternal or donor) will be included. The control group will receive adjustment of total parenteral nutrition (TPN) per NICU guidelines as enteral feedings are advanced followed by standard fortification of human milk. The intervention group will have TPN (protein and lipids) adjusted based on analysis of human milk as feedings are advanced to provide goal 4g/kg/day of protein and 100-130 kcal/kg/day followed by targeted fortification of breast milk based on human milk analysis to continue to provide 4 g/kg/day of protein and 100-130 kcal/kg/day for once full feeds are achieved. The primary aim of this study is to evaluate the growth, anthropometric measurements, and body composition, to see if targeted fortification improves neonatal growth. By optimizing neonatal growth and nutrition there is potential to also have an impact on other morbidities and long term neurodevelopmental outcomes.

Eligibility criteria: Inclusion Criteria:

* Premature infants \<1500 g
* Mother consenting to provide breast milk or use of donor breast milk

Exclusion Criteria:

* Infants with major congenital malformations
* Infants with medical conditions precluding them from having breast milk
* Mothers with medical conditions that preclude them form providing breast milk
* Insufficient breast milk supply
* Refusal of donor breast milk
* Mother is non-English speaking

Primary outcomes:
measure: Body Composition
timeFrame: 4 weeks after baby reaches full feeds (150 mL/kg/day) or at NICU discharge
Secondary outcomes:
measure: Weight Gain Velocity
timeFrame: From enrollment in study to 4 weeks after full feeds (150 mL/kg/day) or at NICU discharge.
measure: Weight Gain
timeFrame: From enrollment in study to 4 weeks at full feeds (150 mL/kg/day) or at NICU discharge.
measure: Linear Growth
timeFrame: From enrollment in study to 4 weeks at full feeds (150 mL/kg/day) or at NICU discharge.
measure: Head Circumference Growth
timeFrame: From enrollment in study to 4 weeks at full feeds (150 mL/kg/day) or at NICU discharge.
measure: Body Composition
timeFrame: From enrollment in study to 4 weeks at full feeds (150 mL/kg/day) or at NICU discharge.
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
Study officials:
affiliation: MetroHealth Medical Center
name: Sharon Groh-Wargo, PhD, RDN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Section on Breastfeeding. Breastfeeding and the use of human milk. Pediatrics. 2012 Mar;129(3):e827-41. doi: 10.1542/peds.2011-3552. Epub 2012 Feb 27.
citation: Martin CR, Ling PR, Blackburn GL. Review of Infant Feeding: Key Features of Breast Milk and Infant Formula. Nutrients. 2016 May 11;8(5):279. doi: 10.3390/nu8050279.
citation: Fusch G, Kwan C, Kotrri G, Fusch C. "Bed Side" Human Milk Analysis in the Neonatal Intensive Care Unit: A Systematic Review. Clin Perinatol. 2017 Mar;44(1):209-267. doi: 10.1016/j.clp.2016.11.001. Epub 2016 Dec 29.
citation: Tudehope DI. Human milk and the nutritional needs of preterm infants. J Pediatr. 2013 Mar;162(3 Suppl):S17-25. doi: 10.1016/j.jpeds.2012.11.049.