Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low Weight Infants
Recruiting
N/A
Interventional Study
Ductus Arteriosus, Patent
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 7 Days – 32 Days
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 240 (estimated)
- Sponsor
- Nationwide Children's Hospital · Other
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About This Trial
Patent Ductus Arteriosus is a developmental condition commonly observed among preterm infants. It is a condition where the opening between the two major blood vessels leading from the heart fail to close after birth. In the womb, the opening (ductus arteriosus) is the normal part of the circulatory system of the baby, but is expected to close at full term birth. If the opening is tiny, the conditi…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. EPIs born between 22-weeks+0 days (220/7 wks) and 27-weeks+6 days (276/7 wks) gestation, inclusive
2. Admitted to a study NICU
3. Birth weight ≥700-grams
4. Mechanically ventilated at time of consent and randomization
5. HSPDA ("PDA Score" ≥6) noted on echocardiogram (ECHO)
6…
Contacts