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:
2025-12-24 @ 5:02 PM
Ignite Modification Date:
2025-12-24 @ 5:02 PM
NCT ID:
NCT06109350
Eligibility Criteria:
Inclusion Criteria:
* Infants born between 28 -34 weeks of gestation
* Medically stable and off ventilator at the time of discharge from the hospital
* Parents who consent to come for follow up
Exclusion Criteria:
* Cortical blindness or retinopathy of prematurity causing blindness
* Musculoskeletal/congenital abnormalities
* Brain injuries including intra-ventricular hemorrhage (grade 3 and above), hypoxic ischemic encephalopathy and hydrocephalus
* Genetic syndrome
* Family who do not consent
* Parent with physical and psychological problems
* Infants with medical devices such as NG tube and gastrostomy
* Infants who have undergone major surgery
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
28 Weeks
Maximum Age:
34 Weeks
Study:
NCT06109350
Study Brief:
Protocol Section:
NCT06109350