Leveraging Optimal Tolerance in Undernourished Infants to Support Growth

Overview

The goal of this study is to learn if InfaCore (IC) an energy and nutrient dense formulation (ENDF) can improve growth and tolerance in infants with or at risk of growth faltering when fed IC.

Detailed description

Rationale: The definition of FG/FTT was established by a group of experts in a report published in 2023 (Cooke et al., 2023). In this report they agreed a fall in weight-for-age z-score (WAZ) of ≥1.0 SD over a period of 1 or more months (excluding the first 2 weeks after birth) which includes at least 2-3 growth measurements (Cooke et al., 2023). It is also important to consider infants at risk who have static weight for extended periods e.g., \>/=4 weeks. FG/FTT affects different populations and is estimated to be 10% of infants globally.

InfaCore (IC) an energy and nutrient dense formulation is indicated for infants and young children with FG/FTT defined above or for those at risk of developing e.g., with static weight for extended periods. At risk infants might include some or all of the following those with congenital heart disease (CHD) admitted for surgical procedures, those with critical illness (CI) or on the PICU, infants cystic fibrosis (CF) or other respiratory conditions including chronic lung disease (CLD), some forms of severe cerebral palsy (CP), and those requiring a surgical procedure or post-surgery.

Objective: To demonstrate growth and tolerance in infants with or at risk of growth faltering when fed IC an Energy and Nutrient Dense Formula (ENDF).

Study design: A prospective, single-centre, single-arm open label pilot study to show growth and tolerance in infants with/at risk of FG/FTT when fed an ENDF for 8 weeks.

Interventions

• Other Infant Formula
  Prospective, single-center, single-arm open label pilot study to show growth and tolerance in infants with/at risk of FG/FTT when fed an ENDF for 8 weeks.

Primary outcome measures

• Body Weight [Time frame: 8 weeks]
• Change in body weight [Time frame: 8 weeks]

Eligibility criteria

Inclusion criteria

• Infants aged from 1 month to </=12 months of age
• Infants taking at least 50% of daily intake from infant formula
• Diagnosis of FG (a fall in WAZ of ≥1.0 SD over 1 month or more - not including the first 2 weeks after birth) or risk of FG (static weight for >/= 1 month)
• Infants >/=37 weeks gestation at time of recruitment
• Parent/ legal guardian willing to provide written informed consent

Exclusion criteria

• Exclusively Breastfed infants
• Infants with other medical problems that might independently affect intake (oral or otherwise) or who have specific nutrient needs not met by IC e.g. some gastrointestinal malformations, some renal and liver conditions, inborn errors of metabolism, galactosemia
• Infants on total parenteral nutrition
• Infants with cow milk protein allergy
• Infants with soy allergy
• Infants who participated in other studies within 2 weeks prior to recruitment
• Situations where the investigator has concerns about the willingness or ability of the parents/caregivers to comply with protocol requirements
• Infants who are on a vegan diet
• Infants who are allergic to fish
• Infants born preterm <37 weeks gestation

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Thailand · 1 center

• Department of Pediatrics, Faculty of Medicine, Chulalongkorn University — Bangkok

Publications

• Zhang H, Gu Y, Mi Y, Jin Y, Fu W, Latour JM. High-energy nutrition in paediatric cardiac critical care patients: a randomized controlled trial. Nurs Crit Care. 2019 Mar;24(2):97-102. doi: 10.1111/nicc.12400. Epub 2018 Dec 9. PMID 30548121
• World Health Organization (WHO). Child Growth Standards. [Online]. Available from: https://www.who.int/tools/child-growth-standards/standards/weight-for-age (Accessed August 2025).
• Joint WHO/FAO/UNU Expert Consultation. Protein and amino acid requirements in human nutrition. World Health Organ Tech Rep Ser. 2007;(935):1-265, back cover. PMID 18330140
• Valla FV, Berthiller J, Gaillard-Le-Roux B, Ford-Chessel C, Ginhoux T, Rooze S, Cour-Andlauer F, Meyer R, Javouhey E. Faltering growth in the critically ill child: prevalence, risk factors, and impaired outcome. Eur J Pediatr. 2018 Mar;177(3):345-353. doi: 10.1007/s00431-017-3062-1. Epub 2017 Dec 14. PMID 29243190
• Shoham J, Duffield A. Proceedings of the World Health Organization/ UNICEF/World Food Programme/United Nations High Commissioner for Refugees Consultation on the management of moderate malnutrition in children under 5 years of age. Food Nutr Bull. 2009 Sep;30(3 Suppl):S464-74. doi: 10.1177/15648265090303S306. No abstract available. PMID 19998867
• Pineda D, Bingham R, Gates A, Thompson AB, Stansfield BK. Osmolality of fortified donor human milk: An experimental study. JPEN J Parenter Enteral Nutr. 2024 Jan;48(1):57-63. doi: 10.1002/jpen.2558. Epub 2023 Sep 17. PMID 37608726
• Novak EM, Innis SM. Impact of maternal dietary n-3 and n-6 fatty acids on milk medium-chain fatty acids and the implications for neonatal liver metabolism. Am J Physiol Endocrinol Metab. 2011 Nov;301(5):E807-17. doi: 10.1152/ajpendo.00225.2011. Epub 2011 Jul 26. PMID 21791621
• Jackson AA. Protein requirements for catch-up growth. Proc Nutr Soc. 1990 Oct;49(3):507-16. doi: 10.1079/pns19900059. No abstract available. PMID 2080182

Identifiers

NCT: NCT07549360 · LOTUSV10

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗