Clinical trial NCT03333174: Prematurity Related Ventilatory Control (PRE-VENT) - Specific Aim 3
Official title: Prematurity-Related Ventilatory Control (PRE-VENT): Role in Respiratory Outcomes Clinical Research Centers (CRC) - Specific Aim 3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant,Premature
Keywords: apnea of prematurity
bradycardia
hypoxemic episode
oxygen delivery
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 25
Sex: ALL
Minimum age (years): 1
Maximum age (years): 98
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

Brief 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

Detailed 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).

Eligibility criteria: 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)

Primary outcomes:
measure: Hypoxemic episode
timeFrame: During 24 hour time periods with either intervention (nasal cannula vs. oxygen environment)
Secondary outcomes:
measure: Bradycardic episode
timeFrame: During 24 hour time periods with either intervention (nasal cannula vs. oxygen environment)
measure: Apnea episodes
timeFrame: During 24 hour time periods with either intervention (nasal cannula vs. oxygen environment)
measure: Hypoxemic time defined as duration of time with SpO2 <85%
timeFrame: During 24 hour time periods with either intervention (nasal cannula vs. oxygen environment)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Regional Neonatal ICU and CCN, University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Namasivayam Ambalavanan
role: PRINCIPAL_INVESTIGATOR
References: