An interventional study of Continuous positive airway pressure and Nasal Cannula in Infant, Newborn, Disease, Hypoxia and Respiratory Distress Syndrome, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2024-01-26.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment
The purpose of this study is to determine if in preterm infants \< 34 weeks' gestation at birth receiving respiratory support with continuous positive airway pressure (CPAP) or nasal cannula (NC), CPAP compared with NC will decrease the number of episodes with oxygen saturations less than 85% of ≥10 seconds in a 24-hour randomized controlled trial. This will be a randomized controlled trial with a 1:1 parallel allocation of infants to CPAP or NC oxygen using stratified permuted block design.
We hope to determine whether in preterm infants \< 34 weeks' gestation at birth receiving respiratory support with continuous positive airway pressure (CPAP) or nasal cannula (NC), CPAP compared with NC will decrease the number of episodes with oxygen saturations less than 85% of ≥10 seconds in a 24-hour randomized controlled trial.
This study will include preterm infants \< 34 weeks' gestation on respiratory support via CPAP with a PEEP ≤ 5 and FiO2 ≤ 30%. There will be two randomization strata [≥ 22+0/7 to ≤ 27+0/7 weeks, and ≥ 27+1/7 to ≤ 33+6/7 weeks. The purpose of stratification is to ensure an appropriate distribution of risk between study arms. This study will not be powered to detect outcome differences within or between strata.
Following informed consent, randomization, stratified by gestational age at delivery, will be performed using sequentially numbered sealed opaque envelopes. Each envelope will indicate either Treatment group (CPAP group) or Control group (NC group). The envelope will only be opened after informed consent has been obtained and just before starting the study on each infant.
This will be a single center randomized controlled trial with a 1:1 parallel allocation of infants to CPAP or NC oxygen using stratified permuted block design. 15-30 minutes will be provided as a washout period at the beginning of the intervention, followed by 24 hours on the intervention. Infants enrolled must meet CPAP stability criteria that are based on prior randomized clinical trials of weaning from CPAP to NC.
All infants enrolled in the study will have routine monitoring, uniform target saturation ranges of 91-95% with alarm limits set at 88-95%, and standard care for the duration of the study. The high alarm limit will be increased to 100% if an infant is weaned to 21% FiO2. Supplemental FiO2 will be titrated per unit routine to achieve goal target saturations. Pulse oximetry recordings will be downloaded using ixTrend (iexcellence, Wildau, Germany) software to a secure computer system or via Bedmaster software for later data analysis. The target oxygen saturations (91 to 95%) are based on data from the meta-analysis of randomized controlled trials of oxygen saturation targets which included data on 4911 infants from the SUPPORT, COT, and BOOST II trials.
Primary and secondary outcomes are described below. Other safety outcomes include recordings of episodes of bradycardia and circumstances surrounding the event. Pulse oximetry recordings will be downloaded using ixTrend software to a secure computer system for later data analysis. Abdominal and cerebral NIRS will also be performed with subsequent data analysis..
1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
This study's enrollment of 38 is below the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
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Exclusion Criteria:
Continuous positive airway pressure (CPAP) with blended oxygen delivered by binasal prongs or nasal mask.
Procedure: Continuous positive airway pressure
Blended oxygen delivered by nasal cannula (NC).
Procedure: Nasal Cannula
After study entry, CPAP will be provided via mask or binasal prongs in order to have a relatively uniform CPAP delivery system among infants in the treatment group. Bubble CPAP will be preferred over other modes of CPAP delivery. A PEEP of 5 will be used for uniformity.
Also known as: CPAP
After study entry, flow will be set to 0.5 L/kg with 1L maximum while on NC during the study period to reduce the risk of inadvertent PEEP with higher flows. Initial FiO2 can be titrated to achieve target saturations, and may be increased up to 100% while on NC.
Also known as: NC
The number of episodes with oxygen saturations less than 85% for ≥ 10 seconds
Time frame: 24 hours of intervention
The coefficient of variability of oxygen saturations (relative standard deviation)
The coefficient of variation is a standardized measure of dispersion of a frequency distribution defined as the ratio of the standard deviation to the mean. It will be used in this study to assess the stability of oxygen saturations.
Time frame: 24 hours of intervention
The proportion of time with oxygen saturations > 95 % among infants requiring supplemental oxygen
Time frame: 24 hours of intervention
The proportion of time spent outside oxygen saturation target ranges (91-95%) among infants requiring supplemental oxygen
Time frame: 24 hours of intervention
The proportion of time with oxygen saturations less than 85%
Time frame: 24 hours of intervention
The median supplemental oxygen concentration
Time frame: 24 hours of intervention
The median transcutaneous carbon dioxide value
Time frame: 24 hours of intervention
The number of episodes (≥ 10 seconds) with oxygen saturations less than 80 %
Time frame: 24 hours of intervention
The number of recorded episodes (≥ 10 seconds) of bradycardia < 100/min
Time frame: 24 hours of intervention
The median cNIRS value
Median cerebral near-infrared spectroscopy value during the 24 hour intervention period
Time frame: 24 hours of intervention
The median aNIRS value
Median abdominal near-infrared spectroscopy value during the 24 hour intervention period
Time frame: 24 hours of intervention
Plan to share: No
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Respiratory Distress Syndrome→
University of Alabama at Birmingham