Infant,Premature
Conditions
Keywords
apnea of prematurity, bradycardia, hypoxemic episode, permissive hypercapnia
Brief summary
To determine if late (at or beyond postnatal day 14) mild permissive hypercapnia is associated with reduction in apnea, bradycardia, and hypoxemic episodes and with improved stability of oxygenation.
Detailed description
Preterm infants who remain intubated or on nasal mechanical ventilation (IMV) at 14 days postnatal age, meet blood gas criteria, have transcutaneous carbondioxide (TcCO2) monitoring with TcCO2 values that trend and correlate appropriately with PaCO2, and are not judged too unstable by Attending neonatologist will qualify. The investigators will use the data from the 96 hours of intensive multiparametric physiologic monitoring at 2 weeks postnatal age. 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 randomly assigned: Intervention 1 (24-48h of data), Intervention 2 (48-72h of data) and Intervention 3 (72-96h of data).
Interventions
DIAGNOSTIC_TESTCardiorespiratory monitoring
We 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).
Sponsors
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The investigators will use the data from the 96 hours of intensive multiparametric physiologic monitoring at 2 weeks postnatal age. The first 24 hours of the data collection will be the baseline data, followed by evaluation of 3 interventions in a cross-over manner, with the initial intervention randomly assigned (computer-generated): Intervention 1 (24-48h of data), Intervention 2 (48-72h), and Intervention 3 (72-96h). The interventions will be to adjust transcutaneous carbondioxide measurements (TcCO2) up or down by 5 mm Hg, while maintaining TcCO2 within usual safe thresholds.
Eligibility
Sex/Gender
ALL
Age
1 Days to 15 Days
Healthy volunteers
No
Inclusion criteria
1. 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 2. Infants eligible for full care and resuscitation as necessary, and surviving beyond 24 h of age 3. Enrollment in main study protocol (Aim 1 of PreVENT Apnea) at \<1 week post-natal age 4. Informed consent from parent/guardian 5. This study will enroll the subset of infants from Aim 1 who are still intubated or on nasal IMV at 2 weeks postnatal age, meet blood gas criteria (arterial or capillary arterialized blood gas values done q12-24h, as most infants do not have an arterial line at 2 weeks: pH \>7.25, PaCO2 \>40 mm Hg), have TcCO2 monitoring with TcCO2 values that trend and correlate appropriately with PaCO2, and are not judged too unstable by the Attending neonatologist.
Exclusion criteria
1. Refusal or withdrawal of consent 2. Major congenital malformations (e.g., not including patent ductus arteriosus, small hernia)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hypoxemic episode | During 24 hour time periods with targeted transcutaneous carbondioxide (TcCO2) | Hypoxemic episode defined as as oxygen saturation by pulse oximetry (SpO2 )\<85% for \>10 seconds |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bradycardic episode | During 24 hour time periods with targeted TcCO2 | Bradycardic episode defined as heart rate (HR) \<100/min for \>10 seconds |
| Apnea episodes | During 24 hour time periods with targeted TcCO2 | Apnea defined as Respiratory Rate (RR)=0 for \>20 seconds, or RR=0 for \>10 seconds + SpO2 \<85% or HR \<100/min |
| Hypoxemic time | During 24 hour time periods with targeted TcCO2 | Hypoxemic time defined as duration of time with SpO2 \<85% |
| Bronchopulmonary dysplasia (BPD) | 36 weeks PMA | BPD defined using physiologic definition at 36w Post-Menstrual Age (PMA) |
Countries
United States
Outcome results
None listed