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Completed

NCT Number: NCT03333161

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

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.

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Key information

About this study

Preterm infants who remain intubated or on nasal mechanical ventilation (IMV) at 14 days postnatal age, meet blood gas criteria, have transcutaneous carbondioxide (TcCO2) monitoring with TcCO2 values that trend and correlate appropriately with PaCO2, and are not judged too unstable by Attending neonatologist will qualify.

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 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), Intervention 2 (48-72h of data) and Intervention 3 (72-96h of data).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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.

Exclusion criteria

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

Treatment and study plan

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).

Primary outcomes

  1. Hypoxemic episode

    Time frame: During 24 hour time periods with targeted transcutaneous carbondioxide (TcCO2)

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

Secondary outcomes

  1. Bradycardic episode

    Time frame: During 24 hour time periods with targeted TcCO2

    Bradycardic episode defined as heart rate (HR) <100/min for >10 seconds

  2. Apnea episodes

    Time frame: During 24 hour time periods with targeted TcCO2

    Apnea defined as Respiratory Rate (RR)=0 for >20 seconds, or RR=0 for >10 seconds + SpO2 <85% or HR <100/min

  3. Hypoxemic time

    Time frame: During 24 hour time periods with targeted TcCO2

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

  4. Bronchopulmonary dysplasia (BPD)

    Time frame: 36 weeks PMA

    BPD defined using physiologic definition at 36w Post-Menstrual Age (PMA)

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 6, 2017
Registry last updated
Sep 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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