NCT07549360

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
12mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 24, 2026

Completed
21 days until next milestone

Study Start

First participant enrolled

May 15, 2026

Expected
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2026

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2027

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

Same day

First QC Date

April 18, 2026

Last Update Submit

April 18, 2026

Conditions

Faltering GrowthFailure to Thrive

Keywords

Faltering GrowthFailure to ThriveEnergy and Nutrient Dense FormulaLOTUSInfacore

Outcome Measures

Primary Outcomes (2)

  • Body Weight

    Body Weight

    8 weeks

  • Change in body weight

    The primary outcome is the change in weight-for-age Z-score from baseline to study completion, regardless of whether the value increases or decreases.

    8 weeks

Study Arms (1)

Interventional

ACTIVE COMPARATOR
Other: Infant Formula

Interventions

Infant FormulaOTHER

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.

Also known as: Energy and Nutrient Dense Infant Formula (ENDF)
Interventional

Eligibility Criteria

Age1 Month - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pediatrics, Faculty of Medicine, Chulalongkorn University

Bangkok, Bangkok, 10330, Thailand

Location

Related Publications (20)

  • 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.

    BACKGROUND

  • 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).

    BACKGROUND

  • World Health Organization (WHO). Technical Report Series. Protein and amino acid requirements in human nutrition. Report of a Joint WHO/FAO/UNU Expert Consultation. World Health Organ Tech Rep Ser 2007;(935):1-265.

    BACKGROUND

  • Valla FV, Berthiller J, Gaillard-Le-Roux B et al. Faltering growth in the critically ill child: prevalence, risk factors, and impaired outcome. Eur J Pediatr. 2018 Mar;177(3):345-353.

    BACKGROUND

  • 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 and Nutrition Bulletin. 2009;30(3_suppl3):S464-S474.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • Jackson AA. Protein requirements for catch-up growth. Proc Nutr Soc 1990; 49: 507-16.

    BACKGROUND

  • Hulst JM, Zwart H, Hop WC, Joosten KF. Dutch national survey to test the STRONGkids nutritional risk screening tool in hospitalized children. Clin Nutr. 2010 Feb;29(1):106-11.

    BACKGROUND

  • Food And Nutrition (FAO). Technical report series 1. 2001. [Online]. Available from: https://openknowledge.fao.org/server/api/core/bitstreams/65875dc7-f8c5-4a70-b0e1-f429793860ae/content (Accessed August 2025)

    BACKGROUND

  • Eveleens RD, Dungen DK, Verbruggen SCAT, Hulst JM, Joosten KFM. Weight improvement with the use of protein and energy enriched nutritional formula in infants with a prolonged PICU stay. J Hum Nutr Diet. 2019 Feb;32(1):3-10.

    BACKGROUND

  • Evans S, Twaissi H, Daly A, Davies P, Macdonald A. Should high-energy infant formula be given at full strength from its first day of usage? J Hum Nutr Diet. 2006 Jun;19(3):191-7; quiz 199-201.

    BACKGROUND

  • Ellis ZM, Tan HSG, Embleton ND, Sangild PT, van Elburg RM. Milk feed osmolality and adverse events in newborn infants and animals: a systematic review. Arch Dis Child Fetal Neonatal Ed. 2019 May;104(3):F333-F340.

    BACKGROUND

  • EUROPEAN DIRECTIVE - COMMISSION DELEGATED REGULATION (EU) (2016) - of 25 September 2015. Supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for food for special medical purposes. 128. [Online]. Available from: file:///C:/Users/garve/Downloads/CELEX_32016R0128_EN_TXT.pdf

    BACKGROUND

  • EUROPEAN DIRECTIVE - COMMISSION DELEGATED REGULATION (EU) (2016). Compositional and information requirements for infant formula and follow-on formula. 127. [Online]. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32016R0127&qid=1650372664210&from=EN. (Accessed 2025)

    BACKGROUND

  • Cooke R, Goulet O, Huysentruyt K, et al. Catch-Up Growth in Infants and Young Children With Faltering Growth: Expert Opinion to Guide General Clinicians. J Pediatr Gastroenterol Nutr. 2023 Jul 1;77(1):7-15.

    BACKGROUND

  • Clarke SE, Evans S, Macdonald A, Davies P, Booth IW. Randomized comparison of a nutrient-dense formula with an energy-supplemented formula for infants with faltering growth. J Hum Nutr Diet. 2007 Aug;20(4):329-39.

    BACKGROUND

  • Braegger C, Decsi T, Dias JA, Hartman C, Kolacek S, Koletzko B, Koletzko S, Mihatsch W, Moreno L, Puntis J, Shamir R, Szajewska H, Turck D, van Goudoever J; ESPGHAN Committee on Nutrition:. Practical approach to paediatric enteral nutrition: a comment by the ESPGHAN committee on nutrition. J Pediatr Gastroenterol Nutr. 2010 Jul;51(1):110-22.

    BACKGROUND

  • Ballard O, Morrow AL. Human milk composition: nutrients and bioactive factors. Pediatr Clin North Am. 2013;60(1):49-74.

    BACKGROUND

  • Alsharkawy A, Foud E, Mujahed A et al. Nutritional assessment and rehabilitation in children with bronchiectasis and childhood interstitial lung diseases: effects on pulmonary functions and clinical severity. Egypt Pediatric Association Gaz 2021;69, 42

    BACKGROUND

MeSH Terms

Conditions

Failure to Thrive

Interventions

Infant Formula

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Milk SubstitutesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood, FormulatedFoods, SpecializedFoodInfant FoodFood and Beverages

Central Study Contacts

Chonnikant Visuthranukul, MD, PhD

CONTACT

+66 2256 4000deknet@gmail.com

Eakkarin Mekangkul, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Prospective, single-center, single-arm open label pilot study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2026

First Posted

April 24, 2026

Study Start (Estimated)

May 15, 2026

Primary Completion (Estimated)

May 15, 2026

Study Completion (Estimated)

May 15, 2027

Last Updated

April 24, 2026

Record last verified: 2026-04

Locations

TH(1)