Prematurity Related Ventilatory Control (PRE-VENT) - Specific Aim 3

Study Overview
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Brief Summary
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To determine if servo-controlled oxygen environment is associated with reduction in (a) bradycardia events, (b) hypoxemic time, (c) bradycardia time, (d) apneic episodes

Detailed Description
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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).

Official Title
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Prematurity-Related Ventilatory Control (PRE-VENT): Role in Respiratory Outcomes Clinical Research Centers (CRC) - Specific Aim 3

Conditions
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Infant,Premature

Intervention / Treatment
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* Diagnostic Test: Cardiorespiratory monitoring


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 98 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: (b) The first 24h of the data collection will be the baseline data. Over the next 72h, we will evaluate 3 interventions in a cross-over manner: Intervention 1 (24-48h of data), Intervention 2 (48-72h), and Intervention 3 (72-96h; same as intervention 1). Initial intervention will be by random assignment (computer-generated). The intervention will be to provide oxygen either by nasal cannula or by servo-controlled oxygen environment, followed by cross-over to other intervention for 24h, and then back to original intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Servo-controlled Oxygen Environment<br>Oxygen will be provided by servo-controlled oxygen environment with adjustment of oxygen concentration (FiO2) to keep infant's oxygen saturation target range at 91-95% 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. | Diagnostic Test: Cardiorespiratory monitoring<br>* 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)<br>|
| Active Comparator: Nasal Cannula Oxygen<br>Oxygen will be provided by nasal cannula with adjustment of flow rate and FiO2 to keep infant's oxygen saturation target range at 91-95% 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. | Diagnostic Test: Cardiorespiratory monitoring<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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apnea of prematurity, bradycardia, hypoxemic episode, oxygen delivery