To study the added advantages of further delay in umbilical cord clamping in preterm neonates.

Delayed cord clamping for 1 minute versus 2-3 minutes in preterm neonates, a double blinded randomised controlled trial. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/09/073297

Enrollment

264

Registered

2024-09-03

Start date

Unknown

Completion date

Unknown

Last updated

2024-09-16

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

Conditions

None listed

Interventions

Intervention1: Delayed umbilical cord clamping for 2-3 minutes.: Delayed clamping of the umbilical cord for 2-3 minutes after birth in preterm neonates. Control Intervention1: Delayed umbilical cord

Eligibility

Inclusion criteria

Inclusion criteria: All preterm babies less than 37 weeks gestational age.

Exclusion criteria

Exclusion criteria: 1. Non vigorous baby. 2. Prenatally diagnosed major congenital anomaly. 3. Intrauterine fetal death. 4. Hydrops. 5. In utero transfusion/laser/amnioreduction. 6. Antepartum Haemorrhage. 7. Active maternal bleeding from abruption/placental disruption at time of delivery, cord tear/avulsion.

Design outcomes

Primary

Measure	Time frame
Neurological outcome at 1 year of age.Timepoint: 12months	—

Secondary

Measure	Time frame
Bronchopulmonary dysplasia.Timepoint: 28 days;Duration of mechanical ventilation in days.Timepoint: 28 days;Duration of phototherapy.Timepoint: 28 days;Haemodynamically significant Patent Ductus Arteriosus requring treatment.Timepoint: 7 days;Highest total bilirubin.Timepoint: 28 days;length of NICU stayTimepoint: 28 days;MortalityTimepoint: 28 days and 1 year;Necrotising Enterocolitis.Timepoint: 28days;Need for inotropes.Timepoint: 1 day, 7 days,28 days;Number of blood transfusions required.Timepoint: 28 days;Periventricular LeukomalaciaTimepoint: 28 days and 1 year;PolycythemiaTimepoint: At 6 hours, 6 weeks after birth;Respiratory distress syndromeTimepoint: 2 days;Retinopathy of prematurity.Timepoint: 21 days,28 days;Severe intraventricular haemorrhage.Timepoint: 28 days	—

Measure

Time frame

Bronchopulmonary dysplasia.Timepoint: 28 days;Duration of mechanical ventilation in days.Timepoint: 28 days;Duration of phototherapy.Timepoint: 28 days;Haemodynamically significant Patent Ductus Arteriosus requring treatment.Timepoint: 7 days;Highest total bilirubin.Timepoint: 28 days;length of NICU stayTimepoint: 28 days;MortalityTimepoint: 28 days and 1 year;Necrotising Enterocolitis.Timepoint: 28days;Need for inotropes.Timepoint: 1 day, 7 days,28 days;Number of blood transfusions required.Timepoint: 28 days;Periventricular LeukomalaciaTimepoint: 28 days and 1 year;PolycythemiaTimepoint: At 6 hours, 6 weeks after birth;Respiratory distress syndromeTimepoint: 2 days;Retinopathy of prematurity.Timepoint: 21 days,28 days;Severe intraventricular haemorrhage.Timepoint: 28 days

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Countries

India

Contacts

Public ContactDr Amruta Amte

Seth GS Medical College and KEM hospital

amruta.amte.aa@gmail.com02224107138

Outcome results