Growth and Feeding Tolerance in Premature Infants | NCT07409038 | Trialant

Growth and Feeding Tolerance in Premature Infants | NCT07409038 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
delayed initiation of human milk fortification on feeding tolerance	Other	delayed initiation of human milk fortification on feeding tolerance	Dietary Supplement: early initiation of human milk fortification on feeding tolerance

Interventions

Name	Type	Description	Arm Group Labels	Other Names
early initiation of human milk fortification on feeding tolerance	Dietary Supplement	early initiation of human milk fortification on feeding tolerance	delayed initiation of human milk fortification on feeding tolerance

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
weight gain	● ≥15-20 g/kg/day (or as per predefined growth standards for preterm infants).	2 to 3 months
● Linear growth & head circumference	Increase in length ≥0.8-1.0 cm/week. Head circumference growth ≥0.5-0.8 cm/week	2 to 3 months

Secondary Outcomes

Measure	Description	Time Frame
● Successful enteral feeding advancement	Achievement of full enteral feeds (≥150 mL/kg/day) without interruption. No need for feed withholding or reduction due to intolerance	2 to 3 months
● Absence of intolerance signs

Contacts/Locations Module

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Background	AlizadehTaheri,P.,Sajjadian, N.,AsGharyanFarge,M.,&Shariat,M.(2017).Isearlybreast milk fortification more effective in preterm infants? A clinical trial: Early and late fortification. InJournal of PerinatalMedicine(Vol. 45, Issue8, pp.953-957). Walter de Gruyter GmbH.https://doi.org/10.1515/jpm-2015-0375