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

Primary Purpose

Infant,Premature

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cardiorespiratory monitoring
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infant,Premature focused on measuring apnea of prematurity, bradycardia, hypoxemic episode, oxygen delivery

Eligibility Criteria

1 Day - 98 Days (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Regional Neonatal ICU and CCN, University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Servo-controlled Oxygen Environment

Nasal Cannula Oxygen

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Hypoxemic episode
Hypoxemic episode defined as as oxygen saturation by pulse oximetry (SpO2) <85% for >10 seconds

Secondary Outcome Measures

Bradycardic episode
Bradycardic episode defined as heart rate (HR) <100/min for >10 seconds
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
Hypoxemic time defined as duration of time with SpO2 <85%
Hypoxemic time defined as duration of time with SpO2 <85%

Full Information

First Posted
November 2, 2017
Last Updated
September 20, 2021
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT03333174
Brief Title
Prematurity Related Ventilatory Control (PRE-VENT) - Specific Aim 3
Official Title
Prematurity-Related Ventilatory Control (PRE-VENT): Role in Respiratory Outcomes Clinical Research Centers (CRC) - Specific Aim 3
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
April 9, 2018 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
July 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant,Premature
Keywords
apnea of prematurity, bradycardia, hypoxemic episode, oxygen delivery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
(b) The first 24h of the data collection will be the baseline data. Over the next 72h, we will evaluate 3 interventions in a cross-over manner: Intervention 1 (24-48h of data), Intervention 2 (48-72h), and Intervention 3 (72-96h; same as intervention 1). Initial intervention will be by random assignment (computer-generated). The intervention will be to provide oxygen either by nasal cannula or by servo-controlled oxygen environment, followed by cross-over to other intervention for 24h, and then back to original intervention.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Servo-controlled Oxygen Environment
Arm Type
Experimental
Arm Description
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.
Arm Title
Nasal Cannula Oxygen
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Cardiorespiratory monitoring
Intervention Description
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)
Primary Outcome Measure Information:
Title
Hypoxemic episode
Description
Hypoxemic episode defined as as oxygen saturation by pulse oximetry (SpO2) <85% for >10 seconds
Time Frame
During 24 hour time periods with either intervention (nasal cannula vs. oxygen environment)
Secondary Outcome Measure Information:
Title
Bradycardic episode
Description
Bradycardic episode defined as heart rate (HR) <100/min for >10 seconds
Time Frame
During 24 hour time periods with either intervention (nasal cannula vs. oxygen environment)
Title
Apnea episodes
Description
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
Time Frame
During 24 hour time periods with either intervention (nasal cannula vs. oxygen environment)
Title
Hypoxemic time defined as duration of time with SpO2 <85%
Description
Hypoxemic time defined as duration of time with SpO2 <85%
Time Frame
During 24 hour time periods with either intervention (nasal cannula vs. oxygen environment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
98 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Namasivayam Ambalavanan
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Regional Neonatal ICU and CCN, University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States

12. IPD Sharing Statement

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

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