Prophylactic DR-CPAP on Late Preterm Infants Born by C-section: an RCT

Study Overview
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Brief Summary
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A Pragmatic Randomized Controlled Pilot Trial to Evaluate the Impact of Early Prophylactic Continuous Positive Airway Pressure with or without Supplemental Oxygen in Spontaneously Breathing Late Preterm Newborn Infants Born by Cesarean Delivery, Compared to No Early Prophylactic Continuous Positive Airway Pressure with or without Supplemental Oxygen, on the Need for Further Respiratory Support Leading to NICU Admissions.

Detailed Description
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A prospective multicenter randomized controlled trial of prophylactic delivery room continuous positive airway pressure (DR-CPAP) versus no prophylactic DR-CPAP will be conducted. Neonates with an obstetrically determined gestational age (GA) from 34 0/7 to 36 6/7 weeks born by Cesarean section (C-section) will be included. Patients to be screened will be identified from the electronic medical record by study personnel or by phone call from admitting physicians or obstetrics (OB) staff. In addition, a research nurse will screen and identify eligible women who are admitted to the OB service daily including labor and delivery or antepartum unit. Eligible women will be approached by a trained research nurse about voluntary participation. If the patient is eligible the study will be introduced by research nurses independent of the treating or admitting physicians, and they will be provided with an informed consent form. Interested participants will be consented either on the antepartum unit or the labor and delivery unit prior to C-section. A total of 122 neonates will be enrolled in the trial, 61 in each group. Since mothers will be randomized to their respective groups immediately prior to C-section, twins will be allocated to the same treatment. Infants will be stratified by site and by GA (34 0/7 to 34 6/7 and 35 0/7 to 36 6/7 weeks). The study will include neonates of both sexes and from all racial and ethnic groups. After obtaining the informed consent the research personnel will complete the eligibility electronic form including the information needed for the stratification (gestational age and site) in the central web based system, Research Electronic Data Capture (REDCap) housed in a secure server. The central REDCap system will provide the group allocation. The neonatal resuscitation team will ensure the required facemask or nasal prongs and the T piece resuscitator are available before delivery. Once the baby is born, the cord will be clamped following local practice and its time will be recorded. Then the initial steps following neonatal resuscitation guidelines will be performed (warming, drying, stimulating, positioning and suctioning if needed). An immediate evaluation of the respiratory status will be performed. If the infant is spontaneously breathing and allocated to the intervention group, they will receive 20 min of 5 to 6 cm water of continuous airway pressure using either a face mask or the appropriate size of nasal prong. Alternatively, spontaneously breathing infants assigned to control group will receive the standard of care with no prophylactic DR-CPAP. In both groups, CPAP can be used to help babies with persistent labored breathing or cyanosis after the initial steps as per the participating institutional neonatal resuscitation protocol. At any time, if the patient does not present spontaneous breathing, an escalation on the resuscitation measures will be performed and the study intervention will be terminated. A disposable pulse oximeter sensor of the appropriate size will be applied to the right wrist or hand as soon as possible. Supplemental oxygen will be provided to achieve the target oxygen saturation following neonatal resuscitation guidelines and both the saturation level and the oxygen concentration will be recorded at 2, 4 and 6 hours after birth. Following delivery room management, all care decisions, including NICU admission, will be at discretion of the clinical team. Participant data will be collected from the electronic medical record and/or from the monitoring equipment used during resuscitation (e.g., body temperature monitor, CPAP settings, and oxygen saturation, etc.). Patient characteristics, delivery room variables, and neonatal outcomes will be recorded in a secure password protected REDCap database. Password-protected access to the database will be limited to CITI trained data entry staff and key personnel and logged using REDCap internal systems. Data exported from REDCap will be stored directly onto OUHSC secure password protected, HIPAA-compliant servers; no data will be stored on desktop, laptop, or handheld devices. Paper consent forms and data collection sheets will be stored in a double locked cabinet in the neonatology research nurse office. Finally, at the completion of the study, the data will be stored for 7 years, per regulatory requirements, in order to complete analysis and apply for additional grants prior to destruction. Standardized data collection forms will be used for collection all clinical outcome data, then entered and managed using REDcap electronic capture tools hosted and managed by the Data Coordinating Center. The REDCap database will be accessible at each study site by study coordinators, who will be limited to seeing data only from their site for protection of the privacy rights of patients at other sites.

Official Title
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Prophylactic Delivery Room Continuous Positive Airway Pressure to Optimize Outcomes in Spontaneously Breathing Late Preterm Neonates Born by Cesarean Section: A Pilot Clinical Trial

Conditions
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Premature Birth

Intervention / Treatment
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* Procedure: Prophylactic Delivery Room Continuous Positive Airway Pressure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inborn newborns delivered by Cesarean section, gestational age between 34 weeks and < 37 weeks. Exclusion Criteria: Major congenital anomalies including pulmonary hypoplasia and lethal life-limiting conditions.

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 5 Minutes

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prophylactic Delivery Room Continuous Positive Airway Pressure<br>If the infant is spontaneously breathing and allocated to the experimental arm, s/he will receive 20 min of 5 cm H2O of prophylactic continuous airway pressure using either a face mask or the appropriate size of nasal prong. | Procedure: Prophylactic Delivery Room Continuous Positive Airway Pressure<br>* Prophylactic Delivery Room Continuous Positive Airway Pressure (DR-CPAP) of 5-6 cm H20 will be provided for 20 minutes through the face mask or the appropriate size of nasal prong after the initial steps as per the participating institution's neonatal resuscitation protocol.<br>* Other names: DR-CPAP;|
| No Intervention: No Prophylactic Delivery Room Continuous Positive Airway Pressure<br>Alternatively, spontaneously breathing infants assigned to control group will receive the standard of care with no prophylactic delivery room continuous positive airway pressure (CPAP). In both groups, CPAP can be used to help babies with persistent labored breathing or cyanosis after the initial steps as per the participating institution's neonatal resuscitation protocol. At any time, if the patient does not present spontaneous breathing, an escalation on the resuscitation measures will be performed and the study intervention will be terminated. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness | Duration of respiratory support including supplemental oxygen | up to 30 days or hospital discharge | 
| Adverse outcomes | Proportion of air leaks and any other safety related adverse outcomes | first 24 hours after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of newborns with protocol adherence and compliance | Facilitators and barriers for infants completing and not completing 20-min prophylactic delivery room continuous positive airway pressure intervention | first 30 minutes after birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neonatal Resuscitation, Clinical Trial, Late Preterm Infants, Lung Aeration, Respiratory Transition