Targeted Nutrition for Moderate to Late Preterm Infants

NCT05515614 | Completed

• 1 other identifier: 5220169
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be comparing the postnatal growth of moderate to late preterm infants in the Neonatal Intensive Care Unit (NICU) born between gestational ages of 30 weeks 0 days to 35 weeks and 6 days who are receiving enteral feeds of mother's own breast milk using the NICU's standard nutritional fortification protocol versus a targeted nutritional fortification protocol.

Conditions

Premature Birth; Breastmilk Collection; Postnatal Growth Restriction

Keywords

Moderate Preterm; Late Preterm; Postnatal growth; Human milk fortification; Human milk analysis; Targeted nutrition

Outcome Measures

Primary Outcomes (7)

• Postnatal growth in weight

  Weight in kilograms

  From date of birth to date of NICU discharge or when breast milk is no longer available, whichever comes first, assessed up to 24 months

• Postnatal growth in length

  Length in centimeters

  From date of birth to date of NICU discharge or when breast milk is no longer available, whichever comes first, assessed up to 24 months

• Postnatal growth in head circumference

  Head circumference in centimeters

  From date of birth to date of NICU discharge or when breast milk is no longer available, whichever comes first, assessed up to 24 months

• Protein level in mother's expressed breastmilk

  Weekly analysis of pooled mother's expressed breast milk to assess for protein level, measured in grams per 100 milliliters

  From date of first breast milk analysis to date of NICU discharge or when breast milk is no longer available, whichever comes first, assessed up to 24 months

• Calories in mother's expressed breastmilk

  Weekly analysis of pooled mother's expressed breast milk to assess for amount of calories, measured in kilocalories per 100 milliliters

  From date of first breast milk analysis to date of NICU discharge or when breast milk is no longer available, whichever comes first, assessed up to 24 months

• Fat content in mother's expressed breastmilk

  Weekly analysis of pooled mother's expressed breast milk to assess for fat content, measured in grams per 100 milliliters

  From date of first breast milk analysis to date of NICU discharge or when breast milk is no longer available, whichever comes first, assessed up to 24 months

• Carbohydrate level in mother's expressed breastmilk

  Weekly analysis of pooled mother's expressed breast milk to assess for carbohydrate level, measured in grams per 100 milliliters

  From date of first breast milk analysis to date of NICU discharge or when breast milk is no longer available, whichever comes first, assessed up to 24 months

Study Arms (2)

Standard Fortification

ACTIVE COMPARATOR

Mother's breast milk will be fortified using Enfamil Liquid Human Milk Fortifier (LHMF) as per standard feeding protocol defined by LLUCH NICU.

Dietary Supplement: Enfamil Liquid Human Milk Fortifier

Targeted Fortification

EXPERIMENTAL

Mother's breast milk will be fortified with modular additives, namely Amino Acid powder, PolyCal, and safflower oil to meet the individual nutritional needs.

Dietary Supplement: Targeted Fortification

Interventions

Targeted Fortification DIETARY_SUPPLEMENT

Mother's breast milk will be fortified in modular fashion based on the level of macronutrients (protein, carbohydrate, and fat) found from analysis using the Miris Human Milk Analyser. For protein supplementation, Amino Acid powder will be utilized as a modular component. For carbohydrate supplementation, PolyCal will be utilized. Mother's breast milk will be fortified in modular fashion. For protein supplementation, Amino Acid powder will be utilized as a modular component. For carbohydrate supplementation, PolyCal will be utilized. For lipid supplementation, safflower oil will be utilized. We will set our goal energy level between 110 - 135 kcal/kg/day, protein level between 3.5 - 4.5 g/kg/day, lipid level between 4.8 - 6.6 g/kg/day, and carbohydrate level between 11.6 - 13.2 g/kg/day. We will regard daily fluid volume to be between 150 to 180 mL/kg/day.

Targeted Fortification

Enfamil Liquid Human Milk Fortifier DIETARY_SUPPLEMENT

Mother's breast milk will be fortified using Enfamil Liquid Human Milk Fortifier as per standard feeding protocol defined by LLUCH NICU manual.

Also known as: LHMF

Standard Fortification

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Singleton preterm infants
• Between 30 weeks 0 days and 35 weeks and 6 days
• Receiving any amount of mother's breast milk as a form of enteral nutrition
• Mother is ≥ 18 y/o

You may not qualify if:

• Not receiving any breast milk
• Congenital anomalies or surgical conditions that interfere with enteral feeding

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University

Loma Linda, California, 92354, United States

Location

Related Publications (7)

• Shapiro-Mendoza CK, Tomashek KM, Kotelchuck M, Barfield W, Nannini A, Weiss J, Declercq E. Effect of late-preterm birth and maternal medical conditions on newborn morbidity risk. Pediatrics. 2008 Feb;121(2):e223-32. doi: 10.1542/peds.2006-3629.

  PMID: 18245397 BACKGROUND

• Radtke JV. The paradox of breastfeeding-associated morbidity among late preterm infants. J Obstet Gynecol Neonatal Nurs. 2011 Jan-Feb;40(1):9-24. doi: 10.1111/j.1552-6909.2010.01211.x.

  PMID: 21244492 BACKGROUND

• Al-Theyab NA, Donovan TJ, Eiby YA, Colditz PB, Lingwood BE. Fat trajectory after birth in very preterm infants mimics healthy term infants. Pediatr Obes. 2019 Mar;14(3):e12472. doi: 10.1111/ijpo.12472. Epub 2018 Sep 26.

  PMID: 30257276 BACKGROUND

• Chmielewska A, Farooqi A, Domellof M, Ohlund I. Lean Tissue Deficit in Preterm Infants Persists up to 4 Months of Age: Results from a Swedish Longitudinal Study. Neonatology. 2020;117(1):80-87. doi: 10.1159/000503292. Epub 2019 Dec 10.

  PMID: 31822002 BACKGROUND

• Rochow N, Fusch G, Ali A, Bhatia A, So HY, Iskander R, Chessell L, El Helou S, Fusch C. Individualized target fortification of breast milk with protein, carbohydrates, and fat for preterm infants: A double-blind randomized controlled trial. Clin Nutr. 2021 Jan;40(1):54-63. doi: 10.1016/j.clnu.2020.04.031. Epub 2020 May 6.

  PMID: 32446787 BACKGROUND

• Chou FS, Yeh HW. Sex differences in postnatal weight gain trajectories of extremely preterm newborns. J Perinatol. 2021 Aug;41(8):1835-1844. doi: 10.1038/s41372-021-01099-2. Epub 2021 May 25.

  PMID: 34035451 BACKGROUND

• Agostoni C, Buonocore G, Carnielli VP, De Curtis M, Darmaun D, Decsi T, Domellof M, Embleton ND, Fusch C, Genzel-Boroviczeny O, Goulet O, Kalhan SC, Kolacek S, Koletzko B, Lapillonne A, Mihatsch W, Moreno L, Neu J, Poindexter B, Puntis J, Putet G, Rigo J, Riskin A, Salle B, Sauer P, Shamir R, Szajewska H, Thureen P, Turck D, van Goudoever JB, Ziegler EE; ESPGHAN Committee on Nutrition. Enteral nutrient supply for preterm infants: commentary from the European Society of Paediatric Gastroenterology, Hepatology and Nutrition Committee on Nutrition. J Pediatr Gastroenterol Nutr. 2010 Jan;50(1):85-91. doi: 10.1097/MPG.0b013e3181adaee0.

  PMID: 19881390 BACKGROUND

Related Links

• CDC Wonder Natality, 2016-2020

MeSH Terms

Conditions

Premature Birth; Breast Milk Expression

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Breast Feeding; Feeding Behavior; Behavior

Study Officials

• Raylene Phillips, MD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Mother, physician team, and study statistician will be blinded to randomization.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Standard nutritional fortification arm (control group): mother's expressed breast milk will be fortified using Enfamil Liquid Human Milk Fortifier (LHMF) as per standard feeding protocol defined by LLUCH NICU Manual. In targeted fortification arm (intervention group), mother's expressed breast milk will be fortified with modular components, Amino Acid power, PolyCal and safflower oil, to meet the individual nutritional needs as determined by NICU dieticians.

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: August 25, 2022
• Study Start: August 17, 2022
• Primary Completion: May 11, 2023
• Study Completion: May 11, 2023
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)