Prematurity Related Ventilatory Control (PRE-VENT) - Specific Aim 2



Status:Recruiting
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:Any
Updated:4/17/2018
Start Date:April 4, 2018
End Date:December 30, 2020
Contact:Deborah Laney, RN MSN
Email:dlaney@peds.uab.edu
Phone:205-934-5771

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Prematurity-Related Ventilatory Control (PRE-VENT): Role in Respiratory Outcomes Clinical Research Centers (CRC)

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.

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 that trend and correlate appropriately with PaCO2, and are not judged too
unstable by Attending neonatologist will qualify.

The investigators will use the data from the 96 hours of intensive multiparametric
physiologic monitoring at 2 weeks postnatal age.

The first 24 hours of data collection will be the baseline data. Over the next 72 hours, the
investigators will evaluate 3 interventions in a cross-over manner with the initial
intervention randomly assigned: Intervention 1 (24-48h of data), Intervention 2 (48-72h of
data) and Intervention 3 (72-96h of data).

Inclusion Criteria:

1. 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

2. Infants eligible for full care and resuscitation as necessary, and surviving beyond 24
h of age

3. Enrollment in main study protocol (Aim 1 of PreVENT Apnea) at <1 week post-natal age

4. Informed consent from parent/guardian

5. 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 Criteria:

1. Refusal or withdrawal of consent

2. Major congenital malformations (e.g., not including patent ductus arteriosus, small
hernia)
We found this trial at
1
site
Birmingham, Alabama 35233
Principal Investigator: Namasivayam Ambalavanan, MD
Phone: 205-934-4680
?
mi
from
Birmingham, AL
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