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

NCT03333174 | Completed

• 1 other identifier: UAB Neo 020
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Conditions

Infant,Premature

Keywords

apnea of prematurity; bradycardia; hypoxemic episode; oxygen delivery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Bradycardic episode

  During 24 hour time periods with either intervention (nasal cannula vs. oxygen environment)

• Apnea episodes

  During 24 hour time periods with either intervention (nasal cannula vs. oxygen environment)

• Hypoxemic time defined as duration of time with SpO2 <85%

  During 24 hour time periods with either intervention (nasal cannula vs. oxygen environment)

Study Arms (2)

Servo-controlled Oxygen Environment

EXPERIMENTAL

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.

Diagnostic Test: Cardiorespiratory monitoring

Nasal Cannula Oxygen

ACTIVE COMPARATOR

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.

Diagnostic Test: Cardiorespiratory monitoring

Interventions

Cardiorespiratory monitoring DIAGNOSTIC_TEST

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)

Nasal Cannula Oxygen; Servo-controlled Oxygen Environment

Eligibility Criteria

• Age: 1 Day - 98 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

Regional Neonatal ICU and CCN, University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Related Publications (1)

• Travers CP, Chahine R, Nakhmani A, Aban I, Carlo WA, Ambalavanan N. Control of breathing in preterm infants on incubator oxygen or nasal cannula oxygen. Pediatr Res. 2025 Feb;97(3):1166-1170. doi: 10.1038/s41390-024-03460-5. Epub 2024 Aug 15.

  PMID: 39147903 DERIVED

MeSH Terms

Conditions

Premature Birth; Apnea; Bradycardia

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes

Study Officials

• Namasivayam Ambalavanan

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: (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.

Study Record Dates

• First Submitted: November 2, 2017
• First Posted: November 6, 2017
• Study Start: April 9, 2018
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: September 21, 2021

Record last verified: 2021-09

Locations

US (1)