Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03333161
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : April 17, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Namasivayam Ambalavanan, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Infant,Premature Diagnostic Test: Cardiorespiratory monitoring Not Applicable

Detailed Description:

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).


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prematurity-Related Ventilatory Control (PRE-VENT): Role in Respiratory Outcomes Clinical Research Centers (CRC)
Actual Study Start Date : April 9, 2018
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : December 30, 2020

Arm Intervention/treatment
Experimental: Higher TcCO2

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
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).

Active Comparator: Lower TcCO2

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
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 Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 15 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. Infants eligible for full care and resuscitation as necessary, and surviving beyond 24 h of age
  3. Enrollment in main study protocol (Aim 1 of PreVENT Apnea) at <1 week post-natal age
  4. Informed consent from parent/guardian
  5. 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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03333161


Contacts
Layout table for location contacts
Contact: Deborah Laney, RN MSN 205-934-5771 dlaney@peds.uab.edu
Contact: Namasivayam Ambalavanan, MD 205-934-4680 ambal@uab.edu

Locations
Layout table for location information
United States, Alabama
Regional Neonatal ICU and CCN, University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Waldemar A Carlo, MD    205-934-4680    wcarlo@peds.uab.edu   
Contact: Namasivayam Ambalavanan, MD    (205) 934-4680    ambal@uab.edu   
Principal Investigator: Namasivayam Ambalavanan, MD         
Principal Investigator: Waldemar A Carlo, MD         
Sponsors and Collaborators
University of Alabama at Birmingham
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
  Study Documents (Full-Text)

Documents provided by Namasivayam Ambalavanan, University of Alabama at Birmingham:

Layout table for additonal information
Responsible Party: Namasivayam Ambalavanan, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03333161     History of Changes
Other Study ID Numbers: UAB Neo 017
U01HL133536 ( U.S. NIH Grant/Contract )
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Namasivayam Ambalavanan, University of Alabama at Birmingham:
apnea of prematurity
bradycardia
hypoxemic episode
permissive hypercapnia
Additional relevant MeSH terms:
Layout table for MeSH terms
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications