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:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT00531102
Eligibility Criteria:
Inclusion Criteria:
1. Inborn
2. ≥35 weeks gestational age
3. Neonatal resuscitation team present at delivery
4. Central cyanosis despite 60 seconds of spontaneous respirations in room air. Sustained respirations are defined as: spontaneous breathing that is regular in rhythm and sufficient to maintain a heart rate ≥100 beats per minute such that provision of artificial tidal volume breathing is not required.
Exclusion Criteria:
1. Lethal anomalies
2. Cyanotic congenital heart disease
3. Known hemoglobinopathy
4. Risk of persistent pulmonary hypertension (eg, meconium aspiration, conditions associated with pulmonary hypoplasia such as prolonged)
5. Known anatomical lung abnormalities
6. Conditions where CPAP is contraindicated (eg, congenital diaphragmatic hernia). Mode of delivery will not be a criterion for inclusion or exclusion.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
1 Minute
Study:
NCT00531102
Study Brief:
Protocol Section:
NCT00531102