Clinical trial NCT05515614: Targeted Nutrition for Moderate to Late Preterm Infants
Official title: Targeted Nutrition for Moderate to Late Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth
Breastmilk Collection
Postnatal Growth Restriction
Keywords: Moderate Preterm
Late Preterm
Postnatal growth
Human milk fortification
Human milk analysis
Targeted nutrition
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2022-08-25
Enrollment: 34
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

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.

Detailed description: Infants in the NICU born between gestational ages 30 weeks 0 days and 35 weeks 6 days will be screened to determine if they are receiving unfortified mother's breast milk for enteral nutrition. Informed consent will be obtained from these lactating mothers for themselves and their infants to participate in the study. Once enrolled in the study, the mother and infant dyad will be randomized using an electronic tool for block randomization into standard fortification arm (control group) or targeted fortification arm (intervention group). Maximum of 100 infants will be assigned to each arm to ensure statistical significance. The physician team, study statisticians, and the mothers will be blinded in their group assignment.

Mothers will be provided with one-on-one teaching (with verbal and written instructions) by the NICU certified lactation consultants or by an authorized, trained study personnel on how to pool their pumped breast milk for 24 hours, referenced as "breast milk pooling." They will also be shown how to prepare a 10 mL sample of the pooled breast milk for analysis. Pooled breast milk will be analyzed for macronutrient content (protein, carbohydrate, fat, and calories) using Miris Human Milk Analyzer before fortification once a week for both arms of the study. All infants in both groups will follow the enteral feeding advancement schedule until the infant is ready for nutritional fortification.

In the standard fortification arm (control group), mother's breast milk will be fortified using Enfamil Liquid Human Milk Fortifier (LHMF) as per standard feeding protocol defined by Loma Linda University Children's Hospital Neonatal Intensive Care Unit. The feeding protocol, specific to birth weight, is available online in the LLUCH NICU Manual.

In the targeted fortification arm (intervention group), 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. Fortification goals for this group will follow the macronutrient intake recommendations for preterm infants published by the European Society of Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) Committee on Nutrition in 2009. The goal energy level will be between 110 - 135 kcal/kg/day, goal protein level between 3.5 - 4.5 g/kg/day, goal lipid level between 4.8 - 6.6 g/kg/day, and goal carbohydrate level between 11.6 - 13.2 g/kg/day. The goal total daily fluid volume will be between 150 to 180 mL/kg/day.

NICU Registered Dietitians will be provided with the macronutrient contents of pooled breast milk from mothers of babies in the intervention group. Using the aforementioned values from ESPGHAN guideline for each macronutrient, they will provide recommendations on specific amounts of modular supplementation to be added to the pooled breast milk. Based on these recommendations, all un-pooled expressed breast milk of mothers in the intervention group will be fortified in a customized manner by the milk technicians in the NICU milk room and given to infants in the intervention group. NICU Registered Dieticians will not be provided with analysis results showing macronutrient levels of the pooled milk or standard fortified milk in the control group as the current standard of care at LLUCH NICU does not include macronutrient analysis of pooled breast milk for babies born \>30 weeks gestation.

Infants enrolled in both arms will have their anthropometric measurements taken once a week from birth to NICU discharge. Anthropometric measurements will include weight, height, and head circumference. The Z-scores of weight, height, and head circumference will be recorded and analyzed for any statistical differences.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Postnatal growth in weight
timeFrame: 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
measure: Postnatal growth in length
timeFrame: 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
measure: Postnatal growth in head circumference
timeFrame: 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
measure: Protein level in mother's expressed breastmilk
timeFrame: 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
measure: Calories in mother's expressed breastmilk
timeFrame: 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
measure: Fat content in mother's expressed breastmilk
timeFrame: 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
measure: Carbohydrate level in mother's expressed breastmilk
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
affiliation: Loma Linda University
name: Raylene Phillips, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.