An interventional study of Chinstrap in Apnea of Prematurity, Intermittent Hypoxemia and Bronchopulmonary Dysplasia of Newborn, sponsored by University of Alabama at Birmingham. Not yet recruiting at 1 site in United States. Open to participants aged 3 Days to 3 Months. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn if a chin strap helps reduce low oxygen episodes in premature babies receiving CPAP or NIPPV (breathing support through the nose). The main question it aims to answer is:
Does wearing a chin strap during CPAP or NIPPV make low oxygen episodes shorter compared to not wearing one?
Researchers will compare the chin strap period to the no-chin-strap period to see if the chin strap shortens low oxygen episodes.
Participants will:
Be randomly assigned to wear the chin strap first or skip it first Wear a soft chin strap for 24 hours, then switch to no chin strap for 24 hours (or the reverse), with a 1-hour break in between Have continuous monitoring of oxygen levels, heart rate, and breathing throughout the 49-hour study
Premature infants commonly receive continuous positive airway pressure (CPAP) or non-invasive positive pressure ventilation (NIPPV) as respiratory support. A frequent and underappreciated problem during nasal CPAP/NIPPV is mouth opening, which disrupts the closed circuit needed for effective positive pressure transmission. This oral air leak reduces effective airway pressure, leads to loss of lung volume, increases work of breathing, and results in respiratory instability. Clinically, this manifests as intermittent hypoxemia (IH) - episodes of oxygen desaturation - and bradycardia.
IH is highly prevalent in preterm infants and carries significant clinical consequences. A secondary analysis of the Canadian Oxygen Trial found that IH episodes lasting more than one minute were independently associated with death or neurodevelopmental impairment at 18 months (RR 1.66; 95% CI 1.35-2.05). The Pre-Vent study (Ambalavanan et al., Am J Respir Crit Care Med. 2023;208:79-97) demonstrated that IH80 duration per event (IH80dpe) - the average duration of episodes with SpO₂ below 80% for at least 10 seconds - was the strongest single predictor of death or invasive mechanical ventilation at 40 weeks postmenstrual age (OR 1.86; 95% CI 1.27-2.71) and grade 3 BPD (OR 1.70; 95% CI 1.18-2.45), supporting its selection as the primary outcome of this trial.
A chin strap is a simple, commercially available soft textile device designed to maintain mouth closure during CPAP. Chin straps are used in many NICUs, including at UAB, as part of standard clinical practice. However, despite widespread empirical use, no randomized controlled trial has evaluated their physiologic impact in preterm infants. Available evidence is limited to small observational studies and adult data from obstructive sleep apnea populations.
Study Design
This is a single-center pilot randomized AB/BA crossover trial. Each enrolled infant serves as their own control, receiving both conditions - a chin strap period and a no-strap period - each lasting 24 hours, separated by a 1-hour washout. Infants are randomized 1:1 to either the AB sequence (chin strap first, then no strap) or the BA sequence (no strap first, then chin strap). Randomization uses sequentially numbered sealed opaque envelopes with permuted block sizes.
Because the effect of the chin strap on IH is expected to be immediate and reversible upon removal, the crossover design is biologically appropriate and reduces the sample size needed compared to a parallel design. The 1-hour washout allows stabilization between periods.
Interventions
During the chin strap period, infants wear the Neotech ChinStrap (Neotech Products LLC), a soft, NeoFoam-based device sized to head circumference, applied to maintain gentle mouth closure. Mouth closure is confirmed by nursing staff with no visible gap between the lips, documented at application and each hourly assessment. During the no-strap period, infants receive standard CPAP/NIPPV without a chin strap, identical to routine clinical care.
CPAP/NIPPV settings are maintained at pre-enrollment levels throughout both periods. A pressure change of ±1 cmH₂O is permitted if clinically needed and must be documented. A change of ≥2 cmH₂O constitutes a protocol deviation. The escalation criterion is FiO₂ requirement greater than 0.70 to maintain SpO₂ within target range.
Monitoring
Continuous physiologic monitoring is performed throughout the 48-hour study period and includes pulse oximetry, transcutaneous CO₂, heart rate, respiratory rate, and nasopharyngeal (NP) pressure. NP pressure is measured using an FDA-cleared nasopharyngeal catheter connected to the NAPA LP-15 Airway Pressure Monitor (DRW Medical LLC). NP pressure reflects effective CPAP pressure delivered to the airway; oral air leak reduces NP pressure, making it a sensitive indicator of CPAP delivery efficiency.
Nursing staff perform hourly assessments including: (a) Mouth Closure Index (MCI) using a 0-3 scale (0 = fully closed, no leak; 1 = small leak; 2 = large leak; 3 = wide open); (b) infant posture (prone vs. supine); and (c) chin strap position and skin integrity. MCI inter-rater reliability will be established prior to study initiation with a target Cohen's kappa ≥0.80.
Outcomes
The primary outcome is IH80dpe (seconds/event) per 24-hour study period. Secondary outcomes include IH80 frequency, IH85 and IH90 frequency and duration per event, time in SpO₂ target range (91-95%), bradycardia frequency, FiO₂, TcCO₂, NP pressure, MCI score, infant posture, respiratory rate, abdominal girth, and feeding intolerance.
Sample Size
Based on Pre-Vent data (IH80dpe 25 ± 6 seconds), a clinically meaningful reduction of 6 seconds (25 to 19 seconds, 24%), 90% power, and two-tailed α = 0.05, a minimum of 11 completers is required by paired t-test (n = (1.96 + 1.282)² × 6²/6² = 10.51). A target of 17 completers was selected for additional robustness. Accounting for 15% attrition, 20 infants will be enrolled.
Statistical Analysis
The primary analysis uses a paired t-test or Wilcoxon signed-rank test comparing IH80dpe between the chin strap and no-strap periods. A linear mixed-effects model with treatment, period, sequence, and carryover as fixed effects serves as a sensitivity analysis. Carryover will be formally tested; if significant (p \< 0.10), only first-period data will be used. Secondary outcomes are analyzed using paired t-tests, Wilcoxon signed-rank tests, or McNemar's test as appropriate. MCI score and posture will be included as covariates in the multivariable model.
1,417 studies on the registry are indexed under Apnea; 152 are open to participants now.
This study's planned enrollment of 20 is below the median of 51 across 962 interventional studies indexed under Apnea.
Browse Apnea studies →University of Alabama at Birmingham is the lead sponsor of 1,416 studies on the registry; 278 are open to participants now.
Of its 160 completed or terminated interventional studies of FDA-regulated products, 128 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Gestational age less than 32 weeks at birth Less than 34 weeks postmenstrual age (PMA) at enrollment Receiving CPAP or NIPPV with PEEP of 5-10 cmH₂O FiO₂ 0.40 or less At least 72 hours of age Clinically stable, defined as no increase in respiratory support settings in the preceding 24 hours
Exclusion Criteria:
Major congenital anomalies Craniofacial abnormalities affecting chin strap fit or mouth closure Active seizures Imminent need for intubation as determined by the treating clinician Known or suspected chromosomal abnormalities Participation in another interventional study that may affect respiratory outcomes Lack of parental consent
Infants randomized to the AB sequence receive a 24-hour chin strap period (Period 1) followed by a 1-hour washout and then a 24-hour no-strap period (Period 2). During Period 1, a soft chin strap (Neotech ChinStrap) is applied to maintain gentle mouth closure during CPAP/NIPPV. During Period 2, standard CPAP/NIPPV is delivered without a chin strap.
Device: Chinstrap
Infants randomized to the BA sequence receive a 24-hour no-strap period (Period 1) followed by a 1-hour washout and then a 24-hour chin strap period (Period 2). During Period 1, standard CPAP/NIPPV is delivered without a chin strap. During Period 2, a soft chin strap (Neotech ChinStrap) is applied to maintain gentle mouth closure during CPAP/NIPPV.
Device: Chinstrap
A soft, commercially available chin strap (Neotech ChinStrap, Neotech Products LLC) applied to maintain gentle mouth closure during CPAP/NIPPV in preterm infants. Size is selected based on head circumference measurement. The device is made of soft, breathable NeoFoam material, is latex-free, and is for single patient use. It is applied by nursing staff and assessed hourly for proper positioning and skin integrity.
IH80 Duration Per Event (IH80dpe)
Average duration per intermittent hypoxemia event with SpO₂ below 80% for at least 10 seconds (IH80dpe), measured in seconds per event per 24-hour study period. Calculated as total cumulative duration of SpO₂ below 80% events divided by the number of events in the 24-hour period.
Time frame: 24-hour study period (each crossover period)
IH80 Frequency
Number of intermittent hypoxemia events with SpO₂ below 80% for at least 10 seconds per 24-hour study period
Time frame: 24-hour study period (each crossover period)
IH85 Frequency
Number of intermittent hypoxemia events with SpO₂ below 85% for at least 10 seconds per 24-hour study period
Time frame: 24-hour study period (each crossover period)
IH85 Duration Per Event (IH85dpe)
Average duration per intermittent hypoxemia event with SpO₂ below 85% for at least 10 seconds, in seconds per event per 24-hour study period
Time frame: 24-hour study period (each crossover period)
IH90 Frequency
Number of intermittent hypoxemia events with SpO₂ below 90% for at least 10 seconds per 24-hour study period
Time frame: 24-hour study period (each crossover period)
IH90 Duration Per Event (IH90dpe)
Average duration per intermittent hypoxemia event with SpO₂ below 90% for at least 10 seconds, in seconds per event per 24-hour study period
Time frame: 24-hour study period (each crossover period)
Time in Target SpO₂ Range
Proportion of time with SpO₂ within the target range of 91-95% per 24-hour study period
Time frame: 24-hour study period (each crossover period)
Bradycardia Frequency
Number of bradycardia episodes (heart rate below 100 bpm for at least 10 seconds) per 24-hour study period
Time frame: 24-hour study period (each crossover period)
Fraction of Inspired Oxygen (FiO₂)
Median FiO₂ required to maintain SpO₂ within target range during the 24-hour study period
Time frame: 24-hour study period (each crossover period)
Transcutaneous CO₂ (TcCO₂)
Median transcutaneous CO₂ in mmHg during the 24-hour study period
Time frame: 24-hour study period (each crossover period)
Nasopharyngeal Pressure (NP Pressure)
Mean nasopharyngeal pressure during the chin strap vs. no-strap period, as a measure of effective CPAP pressure transmission to the airway
Time frame: 24-hour study period (each crossover period)
Respiratory Rate
Median respiratory rate in breaths per minute during the 24-hour study period
Time frame: 24-hour study period (each crossover period)
Respiratory Support Escalation
Occurrence of respiratory support escalation during the 24-hour study period
Time frame: 24-hour study period (each crossover period)
Feeding Intolerance
Occurrence of feeding intolerance during the 24-hour study period, defined as emesis requiring feeding cessation, or abdominal distension requiring NPO status
Time frame: 24-hour study period (each crossover period)
Severe Bradycardia Frequency (Exploratory)
Number of severe bradycardia episodes (heart rate below 80 bpm for at least 10 seconds) per 24-hour study period. High within-subject variance is expected; this outcome will be analyzed as exploratory and descriptive only
Time frame: 24-hour study period (each crossover period)
Plan to share: No — This is a small single-center pilot study. IPD sharing is not planned at this stage. If a future multicenter trial is conducted, data sharing can be addressed at that point.
Start is estimated for Jan 2027; primary completion for Aug 2027, 7 months later.
Of 296 non-industry interventional studies with no phase under Apnea, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 7 months is below that.
Counting every sponsor, half of 354 studies reached it within 23 months; a quarter within 11 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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