Clinical trial NCT03333161: Prematurity Related Ventilatory Control (PRE-VENT) - Specific Aim 2
Official title: Prematurity-Related Ventilatory Control (PRE-VENT): Role in Respiratory Outcomes Clinical Research Centers (CRC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant,Premature
Keywords: apnea of prematurity
bradycardia
hypoxemic episode
permissive hypercapnia
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2017-11-06
Enrollment: 25
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 the data collection will be the baseline data, followed by evaluation of 3 interventions in a cross-over manner, with the initial intervention randomly assigned (computer-generated): Intervention 1 (24-48h of data), Intervention 2 (48-72h), and Intervention 3 (72-96h). The interventions will be to adjust transcutaneous carbondioxide measurements (TcCO2) up or down by 5 mm Hg, while maintaining TcCO2 within usual safe thresholds.
Primary purpose: TREATMENT

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 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).

Eligibility criteria: 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)

Primary outcomes:
measure: Hypoxemic episode
timeFrame: During 24 hour time periods with targeted transcutaneous carbondioxide (TcCO2)
Secondary outcomes:
measure: Bradycardic episode
timeFrame: During 24 hour time periods with targeted TcCO2
measure: Apnea episodes
timeFrame: During 24 hour time periods with targeted TcCO2
measure: Hypoxemic time
timeFrame: During 24 hour time periods with targeted TcCO2
measure: Bronchopulmonary dysplasia (BPD)
timeFrame: 36 weeks PMA
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Regional Neonatal ICU and CCN, University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Namasivayam Ambalavanan, MD
role: PRINCIPAL_INVESTIGATOR
References: