Prematurity-Related Ventilatory Control (PreVent)

January 30, 2023 updated by: Washington University School of Medicine

Physiologic Biomarkers Predicting Ventilatory Instability and Hypoxemia in Pre Mature Infants

The purpose of this research study is to improve our understanding of unstable breathing and heart blood flow patterns seen in premature infants. The investigator will use novel non-invasive measures to understand the determinants of these unstable breathing and heart flow patterns to potentially identify new therapies for their prevention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The investigator will look at results of breathing tests, non-invasive sound wave (ultrasound) test of the heart and blood vessel (Echocardiography), and a sample of blood to see if it is possible for early detection of breathing control and lung blood vessel dysfunction (pulmonary vascular disease) in infants that are at risk for exposure to long term low oxygen levels. A subset of infants will have a magnetic resonance Imaging study (MRI) between 37- 40 weeks gestational age (GA) or at the time of discharge, whichever comes first.

Respiratory tests include:

  • Bedside Physiology Study completed at 28, 32, 36, 40, and 52 weeks GA in conjunction with the respiratory tests. A 90-minute recording will be made using standard recording equipment that includes a conventional pulse oximeter, an EEG, an airflow sampling catheter near the nose, and respiratory inductance plethysmography (RIP) bands. Standard bedside monitoring will continue during the physiologic studies
  • Carotid Body Function Test completed at 32, 36, 40 and 52 weeks GA. This test is to unmask respiratory instability in response to hyperoxia.

  • Challenge Test completed at 36 weeks GA.

    1. Infants receiving nasal cannula flow with or without supplemental oxygen will undergo a Room Air Challenge Test.
    2. Infants on RA alone will undergo a Hypoxia Challenge test.
  • Effects of Nasal Cannula Flow completed at 28, 32, 36, 40 and 52 week's GA. The flow will be increased through a nasal cannula. This test is to see how flow effects the breathing pattern.

A subset of infants will have an MRI between 37-40 weeks GA or before discharge, whichever comes first. The MRI will allow the doctors to look and see if there is any injury present in the brain that can be linked to an abnormal breathing pattern called periodic breathing.

A subset of infants will have an Echocardiogram (Echo) at 32, 36 and 52 weeks GA. The Echo is performed to assess cardiac structure and function. Echocardiography is performed routinely in premature newborns in the Neonatal Intensive Care Unit (NICU). The echocardiogram will be performed at the infant bedside and will be coordinated with bedside nurse. The infant will remain on a cardio-respiratory monitor during the echocardiogram for approximately 15 minutes.

Infants that have an Echo will have a blood sample collected near the time of the Echo, 3-blood samples total. The purpose of collecting the blood sample is to detect if the Fibroblast Growth Factor (FGF2) level is elevated and possibly be a biomarker of early pulmonary hypertension in pre term infants validated with the echo.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
177

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 day to 4 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Infants admitted to the Neonatal Intensive Care Unit who are born between 24 0/7 to 28 7/8 weeks GA

Description

Inclusion Criteria:

  • All infants born between 24 0/7 and 28 6/7 weeks GA admitted to the Neonatal Intensive Care Unit at St. Louis Children's Hospital will be considered for enrollment.

Exclusion Criteria:

  • Infants not likely to survive
  • Infant with significant heart disease
  • Infant with a significant congenital abnormalities of the central nervous system, nose, mouth lungs or ribs, or congenital diseases that affect lung growth
  • Physician refusal
  • Unlikely that the infant will be available for 52-week follow-up visit.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Preterm infant study visits

Preterm infants Study Visits

  1. Bedside Physiology Study at 28, 32, 36, 40, and 52 weeks GA.

  2. Respiratory tests:

    • Carotid Body Function Test will be completed at 32, 36, 40 and 52 weeks GA
    • Room Air Challenge (RAC) or Hypoxia Challenge Test (HCT) will be completed at 36 weeks GA
    • Effects of nasal cannula flow be completed at 28, 32, 36, 40 and 52 weeks GA
  3. Magnetic Resonance Imaging (MRI): Completed on a subset of infants between 37-40 weeks GA or before discharge, whichever comes first.
  4. Echocardiogram (Echo): Completed at 32, 36 and 52 weeks GA
  5. Blood sample: Obtained at 32, 36 and 52 weeks GA
Other: Bedside Physiology study
A 90-minute recording in conjunction with the respiratory evaluations using standard recording equipment that includes a conventional pulse oximeter, an EEG, an airflow sampling catheter near the nose, and respiratory inductance plethysmography (RIP) bands. Standard clinical bedside monitoring will continue during the respiratory evaluations.
Other: Carotid Body Function Test
Infants without nasal cannula will have a nasal cannula placed in their nares. After a 15-minute baseline period and during quiet sleep, the infant will then be exposed to 30 seconds of 100% oxygen (O2) by increasing FiO2. This test will be repeated 3 times, with at least 3 minutes between tests to allow for return of oxygen saturation (SpO2) to baseline values. If oxygen saturations increase to 99% for 15 seconds or the infant is apneic for greater than 5 seconds following initiation of 100% oxygen (O2), the test will be stopped and FiO2 brought back to baseline. Infants in the NICU will be monitored continuously with heart rate, respiratory rate, and SpO2% for 12 hours after Carotid Body Function Test according to NICU standards. Infants discharge who return for Carotid Body Function Test at 40 and 52 weeks PMA will be monitored continuously for 1 hour after the test is finished.
Other: Room Air Challenge
Infants receiving nasal cannula high flow support 3 liters per minute (LPM) or less with or without supplemental O2 at 36 weeks PMA will be eligible. After a 15-minute quiet sleep period, infants' FiO2 will be weaned, in 0.20 decrements for 5 min intervals. Flow then decreased in 10 min intervals, initially in 1 Liter Per Minute (LPM) decrement until nasal cannula flow is 1LPM, and then decreased by 50% decrements to 0.125 LPM then off. If the infant is weaned to room air alone for 15 minutes, not meeting failure criteria, he/she has passed the RAC. Failure of the RAC is defined as occurring when SpO2% falls below 80%, even briefly, or remains less than 90% for 5 consecutive minutes any time during the test, bradycardia (Heart rate [HR] < 80 bpmx 10 sec) or persistent apnea despite stimulation. Infant is returned to the level of support provided before the RAC begun if meets any failure criteria.
Other Names:
  • RAC
Other: Hypoxia Challenge Test

A physician investigator will review 30 minutes of continuous recording made 24 hours prior to test scheduled to identify infants that are at high risk for significant oxygen desaturations during Hypoxemia Challenge.

If subject passes the screening test, the hypoxic challenge will be performed. For the hypoxemia test, a nasal cannula will be placed prior to a 15 minute period of quiet sleep recorded to confirm antecedent stability of ventilatory pattern and SpO2%. During the 15 minutes of quiet sleep, the infant is required to maintain a SpO2 of > 92% in order to undergo the HCT. After the 15-minute baseline recording, HCT will begin using FiO2 = 0.18 for 5 minutes, unless failure criteria is met: SpO2% < 80% even briefly, or SpO2% 80% to 85% for 15 seconds. If infant does not meet failure criteria, infant will be given FiO2 0.15 for 10 minutes. If an infant meets even a single criterion for failure, Hypoxic mixture will be stopped.

Other Names:
  • HCT
Other: Effects of Nasal Cannula Flow

Infants will have nasal catheter in place (NeoTech Premature RAM Cannula). A 15-minute baseline recording of physiologic study parameters prior to initiation. Tested in three groups of infants.

  1. 28 and 32 weeks PMA flow rates increased after a 15-minute baseline period to 3LPM, or by 1LPM to a max of 5LPM for 15 minutes. Infant on Bubble CPAP will be increased 1cm H2O to max 8 cm H2O for 15 minutes.
  2. Infant's that fail the RAC or HCT at 36 weeks with periodic breathing, high flow at 3LPM will be started for 2 minutes or until periodic breathing stops. Infants on Bubble CPAP will not undergo the RAC or HCT. Their pressure is increased by 1cm H20 to max of 8 cm H2O for 15 minutes.
  3. Infant on RA at 40 and 52 weeks PMA with periodic breathing lasting longer than 1 minute during the 15-minute baseline period, flow at 3LPM will be started for 2 minutes or until periodic breathing stops.
Diagnostic test: Magnetic Resonance Imaging
A non-sedating MRI scan will be performed on 3 subsets of infants at 37-40 weeks Post Menstrual Age (PMA), or when infant is within one week of discharge from the NICU. Standard images as well as research images will be obtained. The research images use the same MRI scanner and collection techniques as standard clinical imaging, but provide a more detailed examination of brain anatomy and injury. Collection of these sequences using our standard non-sedated acquisition practices for infants is well tolerated. Infants will be placed in scanner by registered nurse accompanied by radiology technician to assure infants' comfort during scan. Infant will remain on cardio-respiratory monitor during MRI via a pulse oximetry probe. It will take no longer than one hour to complete MRI scan including transportation to radiology unit.
Other Names:
  • MRI
Diagnostic test: Echocardiogram
An echocardiogram (referred to as an ultrasound of the heart on the consent form) will be performed to assess cardiac structure and function. Echocardiograms are performed routinely in premature newborns in the NICU. The Echocardiogram will be performed at the infant bedside and will be coordinated with bedside nurse. The infant will remain on a cardio-respiratory monitor during the echocardiogram for approximately 15 minutes.
Other Names:
  • Echo
Other: Blood Sample
Infants that have echocardiograms will have a blood sample collected near the time the echocardiogram is obtained, 3-blood samples total. The blood sample will only be collected with parental permission on an opt-in or out-basis and collected only with routine clinical labs.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Respiratory phenotype based on physiologic testing
Time Frame: 36 weeks post menstrual age
Categorization of subjects based on physiologic Challenge Tests into one of four respiratory phenotypes.
36 weeks post menstrual age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington University School of Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: James Kemp, MD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 14, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 9, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 9, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 7, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 14, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 31, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201611138
  • 5U01HL133700-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Respiratory Control in Premature Infants

Clinical Trials on Bedside Physiology study

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings