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

NCT03333161 | Completed DMC

• 2 other identifiers: UAB Neo 017U01HL133536
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infant,Premature

Keywords

apnea of prematurity; bradycardia; hypoxemic episode; permissive hypercapnia

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 targeted transcutaneous carbondioxide (TcCO2)

Secondary Outcomes (4)

• Bradycardic episode

  During 24 hour time periods with targeted TcCO2

• Apnea episodes

  During 24 hour time periods with targeted TcCO2

• Hypoxemic time

  During 24 hour time periods with targeted TcCO2

• Bronchopulmonary dysplasia (BPD)

  36 weeks PMA

Study Arms (2)

Higher TcCO2

EXPERIMENTAL

The investigators will evaluate the effects of attempts to increase blood carbon dioxide levels within a narrow range of 5 mm Hg (well within the range of usual clinical practice) 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. The investigators will attempt to adjust PCO2 by 5 mm Hg higher from baseline (to max of 70 mm Hg), as long as pH is \>7.2. The first 24 hours of the 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; Increase TcCO2 by 5 mm Hg), Intervention 2 (48-72h; TcCO2 back to baseline), and Intervention 3 (72-96h; increase TcCO2 again by 5 mm Hg).

Diagnostic Test: Cardiorespiratory monitoring

Lower TcCO2

ACTIVE COMPARATOR

The investigators will evaluate the effects of attempts to decrease blood carbon dioxide levels within a narrow range of 5 mm Hg (well within the range of usual clinical practice) 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. The investigators will attempt to adjust PCO2 by 5 mm Hg lower than baseline (to minimum of 40 mm Hg), as long as pH is \<7.45.

Diagnostic Test: Cardiorespiratory monitoring

Interventions

Cardiorespiratory monitoring DIAGNOSTIC_TEST

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).

Higher TcCO2; Lower TcCO2

Eligibility Criteria

• Age: 1 Day - 15 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
• Informed consent from parent/guardian
• 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.

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
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Regional Neonatal ICU and CCN, University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Related Publications (1)

• Travers CP, Carlo WA, Nakhmani A, Laney D, Chahine RA, Aban I, Ambalavanan N. Late permissive hypercapnia and respiratory stability among very preterm infants: a pilot randomised trial. Arch Dis Child Fetal Neonatal Ed. 2023 Sep;108(5):530-534. doi: 10.1136/archdischild-2022-325166. Epub 2023 Mar 13.

  PMID: 36914233 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, MD

  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: 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 the data collection will be the baseline data, followed by evaluation of 3 interventions in a cross-over manner, with the initial intervention randomly assigned (computer-generated): Intervention 1 (24-48h of data), Intervention 2 (48-72h), and Intervention 3 (72-96h). The interventions will be to adjust transcutaneous carbondioxide measurements (TcCO2) up or down by 5 mm Hg, while maintaining TcCO2 within usual safe thresholds.

Study Record Dates

• First Submitted: November 2, 2017
• First Posted: November 6, 2017
• Study Start: April 9, 2018
• Primary Completion: March 30, 2021
• Study Completion: March 30, 2021
• Last Updated: September 21, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)