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Effectiveness of a machine in automatically stimulating a baby

Efficacy of Apneboot in apnea termination - an RCT.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/07/019967
Enrollment
76
Registered
2019-07-01
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: P284- Other apnea of newborn

Interventions

Intervention1: Apneboot: This is a device which senses heart rate and oxygen saturation and if there is apnea, provides a stimulus to the baby. this will be attached to the baby for 24 hours a day fo

Sponsors

Bempu health Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Preterm neonates born before 34 weeks of gestation will be included is they have an episode of apnea

Exclusion criteria

Exclusion criteria: Babies who are invasively ventilated babies with major congenital anomalies

Design outcomes

Primary

MeasureTime frame
Duration of hypoxia ( oxygen saturation 85%)Timepoint: During study period—

Secondary

MeasureTime frame
Need for stimulation need for bag and mask ventilationTimepoint: hospital stay—

Countries

India

Contacts

Public ContactSsaudamini Nesargi

St. Johns medical College Hospital

saudamini_nesargi@yahoo.com9243472262

Outcome results

None listed

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