Status:
COMPLETED
Prematurity Related Ventilatory Control (PRE-VENT) - Specific Aim 2
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Infant,Premature
Eligibility:
All Genders
1-15 years
Phase:
NA
Brief Summary
To determine if late (at or beyond postnatal day 14) mild permissive hypercapnia is associated with reduction in apnea, bradycardia, and hypoxemic episodes and with improved stability of oxygenation.
Detailed Description
Preterm infants who remain intubated or on nasal mechanical ventilation (IMV) at 14 days postnatal age, meet blood gas criteria, have transcutaneous carbondioxide (TcCO2) monitoring with TcCO2 values ...
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
- Informed consent from parent/guardian
- This study will enroll the subset of infants from Aim 1 who are still intubated or on nasal IMV at 2 weeks postnatal age, meet blood gas criteria (arterial or capillary arterialized blood gas values done q12-24h, as most infants do not have an arterial line at 2 weeks: pH \>7.25, PaCO2 \>40 mm Hg), have TcCO2 monitoring with TcCO2 values that trend and correlate appropriately with PaCO2, and are not judged too unstable by the Attending neonatologist.
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 :
March 30 2021
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03333161
Start Date
April 9 2018
End Date
March 30 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