Comparison of Two Methods of Resuscitation of newborns at the Time of Birth

Efficacy and Safety of RAMs Cannula versus Face Mask in Newborns Requiring Delivery Room Resuscitation: A Randomized Controlled Trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/02/049392

Enrollment

206

Registered

2023-02-01

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: P969- Condition originating in the perinatal period, unspecified

Interventions

Intervention1: Positive pressure ventilation using RAMs Cannula and self-inflating bag: After completing initial steps of resuscitation, positive pressure ventilation will be given using RAMs cannula

Eligibility

Inclusion criteria

Inclusion criteria: After completing the initial steps if a newborn has 1 Apnea or gasping breathing pattern or 2 Limp at birth or 3 Heart rate below 100 per minute

Exclusion criteria

Exclusion criteria: 1 Neonates with major congenital malformations including choanal atresia 2 Neonates with facial trauma/ nasal trauma 3 Failure to obtain consent

Design outcomes

Primary

Measure	Time frame
Proportion of newborns requiring endotracheal intubation after positive pressure ventilation during delivery room resuscitation.Timepoint: During delivery room resuscitation.	—

Secondary

Measure	Time frame
Hospital mortalityTimepoint: During birth hospitalization;Length of hospital stayTimepoint: During birth hospitalization;Need of adrenalineTimepoint: During delivery room resuscitation;Need of chest compressionTimepoint: During delivery room resuscitation;Need of CPAP in first 24 hours of ageTimepoint: First 24 hours of age;Need of IMV in first 24 hours of ageTimepoint: First 24 hours of age;Need of NIV in first 24 hours of ageTimepoint: First 24 hours of age;Need of positive pressure ventilation for more than 1 minuteTimepoint: During delivery room resuscitation;Need of positive pressure ventilation for more than 5 minutesTimepoint: During delivery room resuscitation;Need of ventilation corrective stepsTimepoint: During delivery room resuscitation;Number of breaths needed to achieve visible chest riseTimepoint: During delivery room resuscitation;Preductal oxygen saturation above 85% by 5 minutes of ageTimepoint: Five minutes of age;Proportion of neonates developing HIE and its severityTimepoint: During birth hospitalization	—

Measure

Time frame

Hospital mortalityTimepoint: During birth hospitalization;Length of hospital stayTimepoint: During birth hospitalization;Need of adrenalineTimepoint: During delivery room resuscitation;Need of chest compressionTimepoint: During delivery room resuscitation;Need of CPAP in first 24 hours of ageTimepoint: First 24 hours of age;Need of IMV in first 24 hours of ageTimepoint: First 24 hours of age;Need of NIV in first 24 hours of ageTimepoint: First 24 hours of age;Need of positive pressure ventilation for more than 1 minuteTimepoint: During delivery room resuscitation;Need of positive pressure ventilation for more than 5 minutesTimepoint: During delivery room resuscitation;Need of ventilation corrective stepsTimepoint: During delivery room resuscitation;Number of breaths needed to achieve visible chest riseTimepoint: During delivery room resuscitation;Preductal oxygen saturation above 85% by 5 minutes of ageTimepoint: Five minutes of age;Proportion of neonates developing HIE and its severityTimepoint: During birth hospitalization

—

Countries

India

Contacts

Public ContactMeena Shivani Harishankar

Banaras Hindu University

ashokkumar_bhu@hotmail.com9415300370

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026