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

Not Applicable

Completed

• Conditions: Infant,Premature
• Interventions: Diagnostic Test: Cardiorespiratory monitoring

• Registration Number: NCT03333174
• Lead Sponsor: University of Alabama at Birmingham

Brief 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

Detailed 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).

Study Timeline

• Study First Submitted: 2017-11-02
• Study First Submitted QC: 2017-11-02
• Study First Posted: 2017-11-06
• Study Start: 2018-04-09
• Primary Completion: 2021-07-01
• Study Completion: 2021-07-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-20
• Last Update Posted: 2021-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

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Exclusion Criteria

• Refusal or withdrawal of consent Major congenital malformations (e.g., not including patent ductus arteriosus, small hernia)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nasal Cannula Oxygen	Cardiorespiratory monitoring	Oxygen will be provided by nasal cannula with adjustment of flow rate and FiO2 to keep infant's oxygen saturation target range at 91-95% in a cross-over manner for 24 hours at a time, over a 4-day period, and use Cardiorespiratory Monitoring to evaluate control of breathing.
Servo-controlled Oxygen Environment	Cardiorespiratory monitoring	Oxygen will be provided by servo-controlled oxygen environment with adjustment of oxygen concentration (FiO2) to keep infant's oxygen saturation target range at 91-95% in a cross-over manner for 24 hours at a time, over a 4-day period, and use Cardiorespiratory Monitoring to evaluate control of breathing.

Primary Outcome Measures

Name	Time	Method
Hypoxemic episode	During 24 hour time periods with either intervention (nasal cannula vs. oxygen environment)	Hypoxemic episode defined as as oxygen saturation by pulse oximetry (SpO2) \<85% for \>10 seconds

Secondary Outcome Measures

Name	Time	Method
Apnea episodes	During 24 hour time periods with either intervention (nasal cannula vs. oxygen environment)	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
Bradycardic episode	During 24 hour time periods with either intervention (nasal cannula vs. oxygen environment)	Bradycardic episode defined as heart rate (HR) \<100/min for \>10 seconds
Hypoxemic time defined as duration of time with SpO2 <85%	During 24 hour time periods with either intervention (nasal cannula vs. oxygen environment)	Hypoxemic time defined as duration of time with SpO2 \<85%

Trial Locations

Locations (1)

Regional Neonatal ICU and CCN, University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States