Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03333174
Other study ID # UAB Neo 020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 9, 2018
Est. completion date July 1, 2021

Study information

Verified date September 2021
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

This study will enroll the subset of infants enrolled in the main study (PreVENT Aim 1; 401-1000g at birth and/or 22w 0d-28w 6d; enrolled at <1 week postnatal age; eligible for full care and surviving beyond 24 hours, with informed consent; and with no major malformations) who are receiving oxygen supplementation at 32w and 36w postmenstrual age (PMA), and are not judged too unstable by the Attending neonatologist. For infants on oxygen supplementation at 32w PMA, the investigators will use data from the 96 hours of intensive multiparametric physiologic monitoring at 32w PMA. For infants on oxygen supplementation at 36w PMA, we will use the 96 hours of intensive multiparametric physiologic monitoring at 36w PMA as well as data from the sleep study. 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 (cannula or oxygen environment) randomly assigned: Intervention 1 (24-48h of data), Intervention 2 (48-72h of data) and Intervention 3 (72-96h of data).


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date July 1, 2021
Est. primary completion date July 1, 2021
Accepts healthy volunteers No
Gender All
Age group N/A to 98 Days
Eligibility 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 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 Exclusion Criteria: - Refusal or withdrawal of consent Major congenital malformations (e.g., not including patent ductus arteriosus, small hernia)

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Cardiorespiratory monitoring
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)

Locations

Country Name City State
United States Regional Neonatal ICU and CCN, University of Alabama at Birmingham Birmingham Alabama

Sponsors (1)

Lead Sponsor Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Bradycardic episode Bradycardic episode defined as heart rate (HR) <100/min for >10 seconds During 24 hour time periods with either intervention (nasal cannula vs. oxygen environment)
Secondary Apnea episodes Apnea defined as Respiratory Rate (RR)=0 for >20 seconds, or RR=0 for >10 seconds + oxygen saturation by pulse oximetry (SpO2) <85% or heart rate (HR) <100/min During 24 hour time periods with either intervention (nasal cannula vs. oxygen environment)
Secondary Hypoxemic time defined as duration of time with SpO2 <85% Hypoxemic time defined as duration of time with SpO2 <85% During 24 hour time periods with either intervention (nasal cannula vs. oxygen environment)
See also
  Status Clinical Trial Phase
Completed NCT03445689 - Oxygenation Instability and Maturation of Control of Breathing in Premature Infants
Completed NCT03245723 - Cardiac Function and Metabolism in Young Adults Born Premature (PET-MRI) N/A
Active, not recruiting NCT03575897 - Serial Assessment of Body Fat Accrual in Very Preterm Infants N/A
Completed NCT03082313 - Movement-based Infant Intervention N/A
Completed NCT03696758 - Improving Right Ventricular Function in Young Adults Born Preterm Phase 2
Withdrawn NCT01569633 - Use of Prokinetics in Early Enteral Feeding in Preterm Infants N/A
Terminated NCT03532555 - Enteral Zinc to Improve Growth in Infants at Risk for Bronchopulmonary Dysplasia N/A
Completed NCT03230032 - Pacifier Activated Device and Mother's Voice in Infants at High-risk for Cerebral Palsy N/A
Recruiting NCT03693287 - Personalized vs Standardized PN for Preterm Infants >1250g Phase 4
Terminated NCT03542812 - L-citrulline and Pulmonary Hypertension Associated With Bronchopulmonary Dysplasia Early Phase 1
Completed NCT03434743 - Non-nutritive Sucking and Breastfeeding in Preterm Infants N/A
Active, not recruiting NCT03168516 - Effects of Closed-loop Automatic Control of FiO2 in Extremely Preterm Infants Phase 3
Completed NCT03357458 - Parent-child Interactions, Child Developmental Health, and Health System Costs at 6 Months Corrected Age N/A
Recruiting NCT03521063 - Efficacy of Adding Budesonide to Poractant Alfa to Prevent Bronchopulmonary Dysplasia. Phase 4
Recruiting NCT03501485 - Impact of Protein Supplementation to Mother Milk on Resting Energy Expenditure (REE) in Growing Healthy Preterm Infants.
Recruiting NCT06416956 - Baby-CINO: CaffeINe Treatment Optimisation in Premature Infants
Completed NCT03280381 - Nifty Feeding Cup Versus Generic Medicine Cup Preterm Infants Who Have Difficulty Breastfeeding N/A
Completed NCT03586856 - Comparison of Leakage With Nasal Prongs and Nasal Mask Interface in Newborns Receiving CPAP Treatment N/A
Completed NCT03333161 - Prematurity Related Ventilatory Control (PRE-VENT) - Specific Aim 2 N/A
Active, not recruiting NCT03558737 - Nasal High-frequency Jet Ventilation (nHFJV) Following Extubation in Preterm Infants N/A