Intact cord resuscitation using heart rate as a primary driver versus standard resuscitation among vaginally born term and late preterm infants requiring resuscitation - A randomized control trial

Intact cord resuscitation using heart rate as a primary driver versus standard resuscitation among vaginally born term and late preterm infants requiring resuscitation - A randomized control trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/01/061862

Enrollment

120

Registered

2024-01-25

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

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

Conditions

Health Condition 1: P84- Other problems with newborn

Interventions

Intervention1: Resuscitating new-born primary based on continuous HR monitoring with intact cord resuscitation: THIS STUDY is aimed at neonates requiring resuscitation based on birth among vaginally

Eligibility

Inclusion criteria

Inclusion criteria: More than or equal to 35 weeks POG singleton pregnancy with anticipated vaginal delivery (Gestational age will be assessed by last menstrual period [LMP] or early dating scan if LMP is not available)

Exclusion criteria

Exclusion criteria: 1. Delivery by elective or emergency caesarean section 2. Multiple gestation 3. Antenatally detected life-threatening condition of fetus (e.g., severe hydrops, lethal chromosomal abnormality, severe congenital malformation) 4. Complete placental abruption, Placenta Previa 5. Use of Assisted Reproductive Technology like In Vitro Fertilization After birth 1. Any condition (eg. cord tightly around the neck) necessitating immediate cord clamping and cord cutting based on obstetrics or neonatologist concern 2. Major congenital abnormalities or syndromic infant

Design outcomes

Primary

Measure	Time frame
Incidence of positive pressure ventilation among the two groupTimepoint: First 10 minutes	—

Secondary

Measure	Time frame
1. Need for intubation between the two groups Timepoint: 10 minutes;3. In-hospital mortality between the two groups. 4. To compare the difference in APGAR score at 1,5 and 10 minutes between two grou Timepoint: 10 minutes;Need for chest compression between the two groupsTimepoint: 10 minutes	—

Countries

India

Contacts

Public ContactANURAG PANDEY

AIIMS JODHPUR

neerajpgi@yahoo.co.in8003996908

Outcome results

None listed

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