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 @ 12:00 PM
Ignite Modification Date:
2025-12-24 @ 12:00 PM
NCT ID:
NCT02533661
Eligibility Criteria:
The inclusion criteria for VLBW preterm infants were:
1. birth weight less than 1,500 gram
2. gestational age lower than 37 weeks
The inclusion criteria for parents were:
1. mothers older than 18 years of age;
2. Taiwan nationality
3. absence of maternal substance abuse (alcohol or drug)
4. married or living together at delivery
5. families residing in northern or southern Taiwan.
The exclusion criteria for VLBW preterm infants were:
1. congenital abnormality
2. severe neonatal and perinatal diseases: Severe neonatal diseases refer to major neurologic abnormalities (e.g., seizures, hydrocephalus, ventriculoperitoneal shunt, meningitis, periventricular leukomalacia, grade III-IV intraventricular hemorrhage and stage IV-V retinopathy of prematurity), necrotizing enterocolitis grade II and severe cardiopulmonary disease requiring daily oxygen use at hospital discharge that may require intensive developmental intervention and therefore did not suit for our interventions.
Furthermore, infants exhibiting persistently unstable physiological conditions until 36 weeks' PMA or older, being discharged from hospital at 44 weeks' PMA or older, or developing severe neonatal diseases were early terminated.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
4 Years
Study:
NCT02533661
Study Brief:
Protocol Section:
NCT02533661