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Assessing the feasibility,safety,usability, learnability of ICAN RIPC( ICH centre for advanced research in neonatology -Resuscitation with intact placental circulation)warmer in resuscitating newborn at mothers bedside with intact cord/intact placental circulation- A service evaluation study

Providing support for transition and neonatal resuscitation with intact placental circulation at the mothers bedside: assessing the feasibility,safety,usability and learnability of the ICAN RIPC warmer- A service evaluation study - PRIMARI STUDY

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2016/11/007480
Enrollment
100
Registered
2016-11-24
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- Asphyxia Health Condition 2: P038- Newborn affected by other specified complications of labor and delivery

Interventions

Intervention1: Providing support for transition and neonatal resuscitation with intact placental circulation in ICAN RIPC warmer: Babies, who are included in the study after the parent consent, will b

Sponsors

Nil
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Babies more than 24 weeks gestational age & weight of more than 400 grams.

Exclusion criteria

Exclusion criteria: 1. Pregnancies of higher order 2. Rh Iso immunization 3. Parents not giving consent

Design outcomes

Primary

MeasureTime frame
1. Proportion of enrolled babies in whom all feasibility criterias were satisfied. 2.Proportion of enrolled babies in whom all safety criterias were satisfied. Timepoint: At birth , at the end of resuscitation,5 minutes

Secondary

MeasureTime frame
SUS Scores,Time taken to start initial steps,Positive pressure ventilation,to establish regular respirations,heart rate more than 100/min,Target saturation and heart rate at 1â??, 5â??,Apgar scores at 1,5,10 mts,temperature at 1 mt, 5 mts, at departure and at admission,first blood gas following resuscitation within 2 hours of life, Haemoglobin & PCV at 6 & 24-48 hrs,Need for respiratory support at admission, Mortality at less than 24 hours, 72 hours , 7 days, Post partum hemorrhage in mother Timepoint: at birth,during resuscitation ,1 mt,5 mts,10 mts ,at admission, 6 hrs,24 hrs

Countries

India

Contacts

Public ContactMangalabharathi S

Institute of child health and hospital for children

drmangalabharathi@gmail.com9840786836

Outcome results

None listed

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