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Rubbing different body areas at birth to help newborn babies to breathe

Optimal Site of Rubbing for the Initial Steps of Neonatal Resuscitation: A Three-Arm Randomized Controlled Trial - OptiRub

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/02/062495
Enrollment
180
Registered
2024-02-09
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

Health Condition 1: P289- Respiratory condition of newborn,unspecified

Interventions

Intervention1: Sole rub: In newborn babies not crying or breathing at birth, after providing adequate warmth to the neonate, three to five rubs will be applied at the sole of both the feet simultaneou

Sponsors

All India Institute of Medical Sciences, Rishikesh
Lead Sponsor
Sriparna Basu
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Inborn neonates with gestational age at or above 32 weeks requiring initial steps for delivery room resuscitation as per the American Academy of Pediatrics - American Heart Association (AHA-NRP) 2020 guidelines

Exclusion criteria

Exclusion criteria: 1. Major congenital anomalies 2. Parental decision - not to resuscitate

Design outcomes

Primary

MeasureTime frame
Peripheral oxygen saturation (SpO2)Timepoint: At 5 minutes of life

Secondary

MeasureTime frame
1. Time to first cry/grimace 2. Minute-specific changes in heart rate (HR) and SpO2 for initial 10 minutes 3. Proportion of neonates achieving a target SpO2 of =80% at 5 minutes of life 4. Time to achieve a HR of =100/min and SpO2 of =80% 5. Total duration of initial steps of resuscitation 6. Need, time of initiation and duration of positive pressure ventilation, intubation, chest compressions, and medications 7. Requirement, mode and duration of supplemental oxygen and respiratory support in the delivery room 8. Cerebral regional oxygen saturation (crSO2) at one hour 9. Need for NICU admission 10. Complication, if any, of the procedure 11. Morbidity and mortality during hospital stay 12. Final outcome Timepoint: During hospital stay and at discharge

Countries

India

Contacts

Public ContactSRIPARNA BASU

All India Institute of Medical Sciences, Rishikesh

varshakolachena@gmail.com9963977840

Outcome results

None listed

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