Targeted Breast Milk Fortification for Very Low Birth Weight Infants in the NICU

Neonate Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04025021
• Other study ID #: 19-00200
• Status: Terminated
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: March 31, 2021

Study information

• Verified date: January 2023
• Source: MetroHealth Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Breast Milk
• Human Milk
• Neonate

Intervention

Dietary Supplement:
• Targeted Fortification
The TPN and SMOF lipids will be optimized to provide a goal of 4 g/kg/day of protein, and 100-130kcal/kg/day. At 100 ml/kg/day of enteral feeds additional liquid protein and/or microlipids will be added to the breast milk to provide goal of 4 g/kg/day of protein and 100-130 kcal/kg/day. This will be determined by analysis of the milk and reported composition. They will continue targeted fortification for 4 weeks after achieving full feeds of 150 ml/kg/day.

Device:
• The Miris Human Milk Analyzer
The Miris human milk analyzer is a mid infrared that reports the amount of energy absorbed at each wavelength. The amount of fat (grams), lactose (grams), total protein (grams), true protein (grams), and energy (kcal) per 100 ml will be reported.

Locations

Country	Name	City	State
United States	MetroHealth Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
MetroHealth Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Composition	Body composition will be measured by air displacement plethysmography (PEAPod). As standardized assessment of body composition is relatively new in the preterm infant population, we are using clinical judgment to determine that a difference in fat free mass z-score (from data from Norris T, 2019) of 0.5 is clinically significant.	4 weeks after baby reaches full feeds (150 mL/kg/day) or at NICU discharge
Secondary	Weight Gain Velocity	Weight gain velocity, measured in grams/kg/day	From enrollment in study to 4 weeks after full feeds (150 mL/kg/day) or at NICU discharge.
Secondary	Weight Gain	Daily weight will be obtained, measured in grams	From enrollment in study to 4 weeks at full feeds (150 mL/kg/day) or at NICU discharge.
Secondary	Linear Growth	Weekly measurements of length will be obtained throughout the study, measured in centimeters	From enrollment in study to 4 weeks at full feeds (150 mL/kg/day) or at NICU discharge.
Secondary	Head Circumference Growth	Weekly measurements of head circumference will be obtained throughout the study, measured in centimeters	From enrollment in study to 4 weeks at full feeds (150 mL/kg/day) or at NICU discharge.
Secondary	Body Composition	Mid upper arm circumference (cm) or skinfold thickness (mm) will be measured weekly throughout the study and combined with length to calculate the body composition	From enrollment in study to 4 weeks at full feeds (150 mL/kg/day) or at NICU discharge.

External Links

•   Miris HMA, Human Milk Analyzer website