Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-25 @ 3:48 AM
NCT ID:
NCT03586102
Brief Summary:
The study hypothesis is that, in human milk-fed extremely preterm infants, higher protein intake compared to usual protein intake reduces percent body fat (%BF) at 3 months of age.
Detailed Description:
Qualifying participants will be randomly assigned to receive either standard protein supplementation (control group) or high protein supplementation (intervention group).
Intervention group: A fixed amount of commercially available hydrolyzed bovine protein will be added to fortified human milk after establishment of full enteral feeding.
Control group: Hydrolyzed bovine protein will not be added to fortified human milk after establishment of full enteral feeding.
If parent agrees, stool "dirty" diapers will be collected 2 times (at the time of hospital discharge and at 3 months of corrected age).
Study:
NCT03586102
Study Brief:
Protocol Section:
NCT03586102