Delayed cord clamping at two different time points in healthy premature newborns and its effect on oxygen saturation

Physiological Versus One-Minute Based Delayed Cord Clamping Among Very and Moderate Preterm Infants Not Requiring Resuscitation: A Randomized Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/11/076625

Enrollment

182

Registered

2024-11-11

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-09

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

Conditions

None listed

Interventions

Intervention1: Physiological-based Cord Clamping: Preterm infants (28+0-33+6 weeks) born by vaginal or Caesarean delivery and not requiring resuscitation, the cord will be clamped after separation of

Eligibility

Inclusion criteria

Inclusion criteria: Very and moderate preterm (28+0–33+6 weeks) singleton pregnancy or multifetal gestation (only dizygotic pregnancy) with anticipated delivery irrespective of the mode of delivery, i.e., vaginal and LSCS, either elective or emergency. (Gestational age will be assessed by last menstrual period [LMP] or early dating scan if LMP is not available.)

Exclusion criteria

Exclusion criteria: 1. Multifetal gestation (Other than Dizygotic pregnancy) 2. Suspected or confirmed congenital anomaly or syndrome in the fetus 3. Neonates with major congenital malformation or having syndromic appearance noted at birth 4. Neonates requiring resuscitation immediately after birth. 5. Neonates where PBCC could not be practiced due to any maternal or neonatal reason.

Design outcomes

Primary

Measure	Time frame
To study the time to reach 90% preductal oxygen saturation (SpO2) among very and moderate preterm infants (28+0-33+6weeks) who do not require resuscitation and underwent physiological-based cord clamping (PBCC) compared to one-minute-based delayed cord clamping (DCC)Timepoint: Time taken to reach 90% preductal oxygen saturation	—

Secondary

Measure	Time frame
To compare heart rate, saturation till 10 minutes of life and Expanded Apgar score at 1, 5, and 10 minutes of life.Timepoint: Till 10 minutes of life;To study difference in hematocrit levels at 24(±4) hours among very and moderate preterm infants (28+0-33+6 weeks).Timepoint: 24(±4) hours;Incidence of respiratory distress, need of CPAP alone, mechanical ventilation, and fluid bolus or inotropic support in the first 48 hours of life.Timepoint: First 48 hours of life;Incidence of polycythemia and jaundice requiring treatment with phototherapy or exchange transfusion, or both till discharge, need of blood transfusion during hospital stayTimepoint: Till discharge of patient;To compare the hematological parameters like hemoglobin, MCV, MCHC, Reticulocyte count and Peripheral smear at 4 (±1) weeks of life.Timepoint: 4(±1) weeks of life;To compare incidence of neonatal in-hospital morbidities like IVH (any grade and severe IVH), NEC (any stage and definite NEC), PVL, BPD, PDA requiring treatment, Sepsis (Culture negative and culture positive, early onset and late onset), ROP (any stage), and ROP requiring treatment.Timepoint: Till Discharge of patient;To compare in-hospital mortality among both groups.Timepoint: Till In-hospital stay;Maternal Postpartum haemorrhageTimepoint: Within 24 hours after birth;Maternal in-hospital mortality, need of blood transfusion and ICU admission post-delivery till dischargeTimepoint: Till Discharge	—

Measure

Time frame

To compare heart rate, saturation till 10 minutes of life and Expanded Apgar score at 1, 5, and 10 minutes of life.Timepoint: Till 10 minutes of life;To study difference in hematocrit levels at 24(±4) hours among very and moderate preterm infants (28+0-33+6 weeks).Timepoint: 24(±4) hours;Incidence of respiratory distress, need of CPAP alone, mechanical ventilation, and fluid bolus or inotropic support in the first 48 hours of life.Timepoint: First 48 hours of life;Incidence of polycythemia and jaundice requiring treatment with phototherapy or exchange transfusion, or both till discharge, need of blood transfusion during hospital stayTimepoint: Till discharge of patient;To compare the hematological parameters like hemoglobin, MCV, MCHC, Reticulocyte count and Peripheral smear at 4 (±1) weeks of life.Timepoint: 4(±1) weeks of life;To compare incidence of neonatal in-hospital morbidities like IVH (any grade and severe IVH), NEC (any stage and definite NEC), PVL, BPD, PDA requiring treatment, Sepsis (Culture negative and culture positive, early onset and late onset), ROP (any stage), and ROP requiring treatment.Timepoint: Till Discharge of patient;To compare in-hospital mortality among both groups.Timepoint: Till In-hospital stay;Maternal Postpartum haemorrhageTimepoint: Within 24 hours after birth;Maternal in-hospital mortality, need of blood transfusion and ICU admission post-delivery till dischargeTimepoint: Till Discharge

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Countries

India

Contacts

Public ContactDr Gudipudi Sai Vamsi Manoj

All India Institute of Medical Sciences, Jodhpur

neerajpgi@yahoo.co.in8003996908

Outcome results