Status:
COMPLETED
Prematurity Related Ventilatory Control (PRE-VENT) - Specific Aim 3
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Infant,Premature
Eligibility:
All Genders
1-98 years
Phase:
NA
Brief Summary
To determine if servo-controlled oxygen environment is associated with reduction in (a) bradycardia events, (b) hypoxemic time, (c) bradycardia time, (d) apneic episodes
Detailed Description
This study will enroll the subset of infants enrolled in the main study (PreVENT Aim 1; 401-1000g at birth and/or 22w 0d-28w 6d; enrolled at \<1 week postnatal age; eligible for full care and survivin...
Eligibility Criteria
Inclusion
- \- Inborn infants weighing 401-1,000 grams on admission and/or 22w 0/7d to 28w 6/7d (\<29 weeks) inclusive completed weeks of gestation
- Infants eligible for full care and resuscitation as necessary, and surviving beyond 24 h of age
- Enrollment in main study protocol (Aim 1 of PreVENT Apnea) at \<1 week post-natal age
- This study will enroll the subset of infants from Aim 1 who are receiving oxygen supplementation at 32w and 36w PMA, and are not judged too unstable by the Attending neonatologist
- Informed consent from parent/guardian
Exclusion
- \- Refusal or withdrawal of consent Major congenital malformations (e.g., not including patent ductus arteriosus, small hernia)
Key Trial Info
Start Date :
April 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2021
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03333174
Start Date
April 9 2018
End Date
July 1 2021
Last Update
September 21 2021
Active Locations (1)
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1
Regional Neonatal ICU and CCN, University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233