Clinical trial NCT05204719: Prophylactic DR-CPAP on Late Preterm Infants Born by C-section: an RCT
Official title: Prophylactic Delivery Room Continuous Positive Airway Pressure to Optimize Outcomes in Spontaneously Breathing Late Preterm Neonates Born by Cesarean Section: A Pilot Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Premature Birth
Keywords: Neonatal Resuscitation
Clinical Trial
Late Preterm Infants
Lung Aeration
Respiratory Transition
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: Pontificia Universidad Catolica de Chile
name: Columbia University
name: St. Louis University
name: University of Alberta
name: Indiana University
First posted: 2022-01-24
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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 120 neonates will be enrolled in the trial, 60 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. 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 (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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Effectiveness
timeFrame: up to 30 days or hospital discharge
measure: Adverse outcomes
timeFrame: first 24 hours after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: New York
country: United States
facility: Columbia University
state: New York
city: Oklahoma City
country: United States
facility: Oklahoma Children's Hospital at OU Health
state: Oklahoma
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Santiago
country: Chile
facility: Pontificia Universidad Católica de Chile
state: Región Metropolitana
Study officials:
affiliation: Univeristy of Oklahoma Health Sciences Center
name: Birju A Shah, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shah BA, Fabres JG, Leone TA, Schmolzer GM, Szyld EG; International Liaison Committee on Resuscitation Neonatal Life Support Task Force. Continuous positive airway pressure for term and >/=34+0 weeks' gestation newborns at birth: A systematic review. Resusc Plus. 2022 Nov 8;12:100320. doi: 10.1016/j.resplu.2022.100320. eCollection 2022 Dec.