Outcomes of preterm neonates less than equal to 32 weeks of gestational age with intact cord resuscitation a prospective observational analytical study.
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Dr. Ayan Das
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Decreased need of invasive or non invasive respiratory support.
Overview
Brief Summary
This randomized controlled trial (RCT) aims to evaluate the outcomes of preterm neonates (<32 weeks gestation) undergoing intact cord resuscitation (ICR) compared to the current standard practice of immediate cord clamping during resuscitation. The study is being conducted in the Labour Room and EDEN OT of Medical College and Hospital, Kolkata. Eligible neonates are randomized into intervention and control groups. Primary outcomes include survival and short-term neonatal morbidities (e.g., respiratory distress, need for ventilation, intraventricular hemorrhage). Secondary outcomes assess adaptation parameters and early complications. The trial is designed to generate evidence on the feasibility and benefits of ICR in extremely preterm neonates, with the goal of improving neonatal survival and reducing complications.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 1.00 Day(s) to 90.00 Day(s) (—)
- Sex
- All
Inclusion Criteria
- •Gestational age less than equal to 32 weeks .
- •Inborn neonates delivered at MCH, Kolkata.
- •Neonates receiving resuscitation with intact cord.
Exclusion Criteria
- •Maternal HIV infection
- •Maternal Hepatitis B infection
- •Rh-negative pregnancy
- •Antepartum hemorrhage, including: a.
- •Placenta previa b.
- •Abruptio placentae
- •Mothers who do not provide informed consent
- •Major congenital anomalies
- •Cord complications such as: a.
- •Cord prolapse
Outcomes
Primary Outcomes
Decreased need of invasive or non invasive respiratory support.
Time Frame: 3 months
Secondary Outcomes
- 1.Decreased incidence of retinopathy of prematurity.(2.Decreased incidence of intraventricular hemorrhage.)
Investigators
Dr Ayan Das
Medical College and Hospital Kolkata