UAB Neo 017

About this trial

Last updated 4 years ago

Study ID

UAB Neo 017

Status

Completed

Type

Interventional

Phase

N/A

Placebo

Accepting

1 to 15 Years

All

Not accepting

Healthy Volunteers

Trial Timing

Ended 4 years ago

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.

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)

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