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Routine care versus initial steps at birth in preterm infants - A randomized controlled trial

Routine care versus initial steps at birth in moderate to late preterm infants - A randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/09/036730
Enrollment
100
Registered
2021-09-22
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

Health Condition 1: P073- Preterm [premature] newborn [other]

Interventions

Intervention1: Routine care: Immediately after birth the neonate will be placed on the motherâ??s abdomen and dried. If needed, secretions will be wiped from mouth and nose using a cotton gauge. Simul

Sponsors

Dr Deepak Chawla
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All neonates born at 33(0/7) to 36(6/7) weeks of gestation by vaginal delivery irrespective of birth weight and assessed to be breathing/crying at birth would be eligible for enrolment in the study

Exclusion criteria

Exclusion criteria: 1. Major congenital malformation 2. Acute medical or pregnancy complications precluding skin-to-skin contact at birth 3. Multiple gestation (if more than one fetus is born alive) 4. Confirmed or suspected COVID-19 infection in mother

Design outcomes

Primary

MeasureTime frame
Stability of Cardio-Respiratory system in Preterm (SCRIP) scoreTimepoint: At 1, 5,10,15,30,45,60 minutes after birth

Secondary

MeasureTime frame
Axillary TemperatureTimepoint: 60 minutes after birth;Blood sugarTimepoint: 2-hour, 6-hour, 12-hour, 24- hour, 48-hour, 72-hour of life;Duration of hospital stayTimepoint: On discharge;Establishment of successful breastfeedingTimepoint: 0-60 minutes, 12-24 h, 24- 48 h, 48-72 h;Exclusive breastfeedingTimepoint: On discharge;Need of IV antibiotics (duration in days)Timepoint: During hospital stay;Need of IV fluids (Duration in days)Timepoint: During hospital stay;Need of NICU admission (Duration of NICU admission)Timepoint: During hospital stay;Need of respiratory support (Duration of respiratory support)Timepoint: During hospital stay;Weight of babyTimepoint: Daily till discharge

Countries

India

Contacts

Public ContactDr Deepak Chawla

government medical college and hospital

drdeepak@gmch.gov.in9646121559

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 11, 2026