Prematurity Related Ventilatory Control (PRE-VENT) - Specific Aim 3

Infant,Premature Clinical Trial

Official title:

Prematurity-Related Ventilatory Control (PRE-VENT): Role in Respiratory Outcomes Clinical Research Centers (CRC) - Specific Aim 3

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03333174
• Other study ID #: UAB Neo 020
• Status: Completed
• Phase: N/A
• Start date: April 9, 2018
• Est. completion date: July 1, 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 servo-controlled oxygen environment is associated with reduction in (a) bradycardia events, (b) hypoxemic time, (c) bradycardia time, (d) apneic episodes

Description:

This study will enroll the subset of infants enrolled in the main study (PreVENT Aim 1; 401-1000g at birth and/or 22w 0d-28w 6d; enrolled at <1 week postnatal age; eligible for full care and surviving beyond 24 hours, with informed consent; and with no major malformations) who are receiving oxygen supplementation at 32w and 36w postmenstrual age (PMA), and are not judged too unstable by the Attending neonatologist.

For infants on oxygen supplementation at 32w PMA, the investigators will use data from the 96 hours of intensive multiparametric physiologic monitoring at 32w PMA. For infants on oxygen supplementation at 36w PMA, we will use the 96 hours of intensive multiparametric physiologic monitoring at 36w PMA as well as data from the sleep study.

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 (cannula or oxygen environment) 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: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 98 Days

Eligibility

Inclusion Criteria:

• 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

This study will enroll the subset of infants from Aim 1 who are receiving oxygen supplementation at 32w and 36w PMA, and are not judged too unstable by the Attending neonatologist

Informed consent from parent/guardian

Exclusion Criteria:

• Refusal or withdrawal of consent 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
The investigators 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 (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

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 either intervention (nasal cannula vs. oxygen environment)
Secondary	Bradycardic episode	Bradycardic episode defined as heart rate (HR) <100/min for >10 seconds	During 24 hour time periods with either intervention (nasal cannula vs. oxygen environment)
Secondary	Apnea episodes	Apnea defined as Respiratory Rate (RR)=0 for >20 seconds, or RR=0 for >10 seconds + oxygen saturation by pulse oximetry (SpO2) <85% or heart rate (HR) <100/min	During 24 hour time periods with either intervention (nasal cannula vs. oxygen environment)
Secondary	Hypoxemic time defined as duration of time with SpO2 <85%	Hypoxemic time defined as duration of time with SpO2 <85%	During 24 hour time periods with either intervention (nasal cannula vs. oxygen environment)