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

NCT04025021 | Terminated Results FDA Device

• 1 other identifier: 19-00200
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Milk; Neonate; Breast Milk

Keywords

Targeted Fortification; Human Milk Analysis; Neonatal Nutrition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Weight Gain Velocity

  From enrollment in study to 4 weeks after full feeds (150 mL/kg/day) or at NICU discharge.

• Weight Gain

  From enrollment in study to 4 weeks at full feeds (150 mL/kg/day) or at NICU discharge.

• Linear Growth

  From enrollment in study to 4 weeks at full feeds (150 mL/kg/day) or at NICU discharge.

• Head Circumference Growth

  From enrollment in study to 4 weeks at full feeds (150 mL/kg/day) or at NICU discharge.

• Body Composition

  From enrollment in study to 4 weeks at full feeds (150 mL/kg/day) or at NICU discharge.

Study Arms (2)

Control group (standard fortification)

NO INTERVENTION

Breast milk will be fortified standard with Similac Human Milk Fortifier 1 packet: 50 ml breast milk at 50ml/kg/day enteral feeds, then 1 packet:25 ml breast milk at 75 ml/kg/day. As feedings are advanced to goal of 150 ml/kg/day, the TPN and SMOF lipids (Fat Emulsion Comprised of Soy Oil, Medium Chain Triglycerides, Olive Oil, and Fish Oil) will be decreased per standard management and NICU guidelines.

Intervention group (targeted fortification)

EXPERIMENTAL

Breast milk will be fortified standard with Similac Human Milk Fortifier 1 packet: 50 ml breast milk at 50ml/kg/day enteral feeds, then 1 packet:25 ml breast milk at 75 ml/kg/day. During this time, as the volume decreases, 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. Breast milk analysis will occur on a weekly basis immediately after birth for all infants enrolled in the study.

Dietary Supplement: Targeted Fortification; Device: The Miris Human Milk Analyzer

Interventions

Targeted Fortification DIETARY_SUPPLEMENT

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.

Intervention group (targeted fortification)

The Miris Human Milk Analyzer DEVICE

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.

Intervention group (targeted fortification)

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• MetroHealth Medical Center: lead

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Related Publications (4)

• 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.

  PMID: 22371471 BACKGROUND

• 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.

  PMID: 27187450 BACKGROUND

• 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.

  PMID: 28159207 BACKGROUND

• 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.

  PMID: 23445843 BACKGROUND

Related Links

• Miris HMA, Human Milk Analyzer website

Limitations and Caveats

Early termination of the study due to the onset of the COVID pandemic. As a result, no data were analyzed or collected from participants enrolled. Therefore, there are no data to provide for outcome measures and adverse events.

Results Point of Contact

• Title: Stephanie Merlino Barr
• Organization: MetroHealth Medical Center

SMERLINO@METROHEALTH.ORG

216-778-3269

Study Officials

• Sharon Groh-Wargo, PhD, RDN

  MetroHealth Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: After randomization, the groups will not be blinded to the investigators or caregivers.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Neonatal Nutritionist, Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 18, 2019
• Study Start: October 1, 2019
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: February 23, 2023
• Results First Posted: February 23, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)