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Foot operated bag and mask to revive newborn.

Clinical evaluation of a foot operated manual resuscitator in neonates with birth asphyxia.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/09/015730
Enrollment
66
Registered
2018-09-17
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- NEONATES WITH BIRTH ASPHYXIA

Interventions

Intervention1: RESUSCITATION BY FOOT OPERATED METHOD: IN this method newborns with birth asphyxia are resuscitated by foot operated device. Control Intervention1: RESUSCITATION BY BAG AND MASK.: In th

Sponsors

SWAMI DAYANAND HOSPITAL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: neonates >35 weeks gestation requiring resuscitation and meeting pre existing criteria for bag and mask ventilation(as per navjat shishu suraksha karyakaram and helping babies breathe programme)

Exclusion criteria

Exclusion criteria: 1)All newborn babies not requiring any respiratory support. 2)Newborns 3)Newborns with major congenital malformation(neural tube defect,facial defect and abdominal wall defect) 4)newborns qualifying for departmental criteria for intubation without a trial of bag and mask ventilation (congenital diaphragmatic hernia)

Design outcomes

Primary

MeasureTime frame
Success as defined by increase in heart rate by(more than 100 beats per minute)after 30 seconds of resuscitation either by second assess/three lead ecg/pulse oximeter.Timepoint: Success as defined by increase in heart rate by(more than 100 beats per minute)after 30 seconds of resuscitation either by second assess/three lead ecg/pulse oximeter.

Secondary

MeasureTime frame
1)Overall outcome of resuscitatioin. 2)Number of neonates intubated. 3)Number of neonates admitted to NICU. 4)Number of neonatal deaths.Timepoint: 30 seconds

Countries

India

Contacts

Public ContactDR SYED MOHD ARSHAD

SWAMI DAYANAND HOSPITAL

drbisht03@gmail.com9650012819

Outcome results

None listed

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