Eligibility Module

Eligibility Module

The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.

Eligibility Module path is as follows:

Study -> Protocol Section -> Eligibility Module

Eligibility Module


Ignite Creation Date: 2025-12-26 @ 11:47 AM
Ignite Modification Date: 2025-12-26 @ 11:47 AM
NCT ID: NCT03419416
Eligibility Criteria: Inclusion Criteria: * All newborns who are less than 2000 gm born within the study facilities during the study period. Exclusion Criteria: * Newborns who are sick per predefined criteria will not be provided KMC until they have been stabilized. Criteria for delay of initiation include: critical illness including apnea, decreased respiratory rate \<20 breaths per minute, grunting, cyanosis, severe chest in-drawing, convulsions, unconsciousness, and severe hypothermia \<32°F.
Healthy Volunteers: False
Sex: ALL
Minimum Age: 1 Day
Maximum Age: 28 Days
Study: NCT03419416
Study Brief:
Protocol Section: NCT03419416