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

Infant,Premature Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03333161
• Other study ID #: UAB Neo 017
• Secondary ID: U01HL133536
• Status: Completed
• Phase: N/A
• Start date: April 9, 2018
• Est. completion date: March 30, 2021

Study information

• Verified date: September 2021
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 15 Days

Eligibility

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)

Related Conditions & MeSH terms

• Infant,Premature
• Premature Birth

Intervention

Diagnostic Test:
• Cardiorespiratory monitoring
We will use high resolution physiologic monitoring of Heart Rate, Respiratory Rate, Pulse oximetry, (and near-infrared monitoring as well as microcapnography in selected infants) to evaluate control of breathing (apnea, bradycardia, desaturations).

Locations

Country	Name	City	State
United States	Regional Neonatal ICU and CCN, University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (3)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypoxemic episode	Hypoxemic episode defined as as oxygen saturation by pulse oximetry (SpO2 )<85% for >10 seconds	During 24 hour time periods with targeted transcutaneous carbondioxide (TcCO2)
Secondary	Bradycardic episode	Bradycardic episode defined as heart rate (HR) <100/min for >10 seconds	During 24 hour time periods with targeted TcCO2
Secondary	Apnea episodes	Apnea defined as Respiratory Rate (RR)=0 for >20 seconds, or RR=0 for >10 seconds + SpO2 <85% or HR <100/min	During 24 hour time periods with targeted TcCO2
Secondary	Hypoxemic time	Hypoxemic time defined as duration of time with SpO2 <85%	During 24 hour time periods with targeted TcCO2
Secondary	Bronchopulmonary dysplasia (BPD)	BPD defined using physiologic definition at 36w Post-Menstrual Age (PMA)	36 weeks PMA