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Umbilical Cord Milking Versus Immediate Cord Clamping in Full Term Neonates (≥ 37 Weeks) Requiring Resuscitation

Primary Purpose

Hypoxic-Ischemic Encephalopathy, Perinatal Asphyxia

Status
Recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Umbilical cord milking
Immediate cord clamping
Sponsored by
Lady Hardinge Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypoxic-Ischemic Encephalopathy

Eligibility Criteria

37 Weeks - 41 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Vaginally born, Singleton Term gestation (≥ 37 and & < 42 weeks), requiring resuscitation at birth Exclusion Criteria: Major congenital anomaly (antenatally diagnosed or visible at birth) Rh negative pregnancy Hydrops Abruptio Placneta/ Placenta previa Fetus with absent and reversal of End Diastolic flow Cord avulsion Refusal of consent

Sites / Locations

  • Lady Hardinge Medical collegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Umbilical cord milking

Immediate cord clamping

Arm Description

20 cm of umbilical cord would be milked towards the infant with intact umbilical cord. The cord milking will be done four times. The entire procedure can be done in 15-20 seconds

clamping the umbilical cord as soon as possible (average 30 seconds)

Outcomes

Primary Outcome Measures

Incidence of Hypoxic Ischemic Encephalopathy
any stage as per Sarnat and Sarnat Staging

Secondary Outcome Measures

Proportion requiring NICU admission
NICU admission due to any reason
Level of hypoxic ischemic encephalopathy ( mild, moderate or severe)
Level of hypoxic ischemic encephalopathy as per Sarnat and Sarnat Staging
Received blood products or saline bolus or inotropes to support blood pressure
Hypotension requiring blood products or saline bolus or inotropes
Length of hospital stay
Duration of stay in days
Mean Blood Pressure at 2,6,12,24,48,72 hrs
Mean Blood Pressure as assessed by non-invasive oscillometric method
Hyperbilirubinemia requiring phototherapy
As per AAP charts
Proportion of neonates having APGAR score < 4 at 5 minutes of life
APGAR score (Min zero maximum Ten) assessed at 1,5 minutes (Low APGAR is bad prognosis and High APGAR is good prognosis)
Neonates requiring Initial steps of resuscitation, Bag and Mask Ventilation, Intubation, chest compression and administration of drugs during resuscitation.
As per NRP 2015 guidelines
Proportion of neonates developing polycythemia
Polycythemia is defined as venous hematocrit >65%
Proportion of mortality due to any cause
Including early and late neonatal deaths

Full Information

First Posted
October 13, 2023
Last Updated
October 19, 2023
Sponsor
Lady Hardinge Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT06090968
Brief Title
Umbilical Cord Milking Versus Immediate Cord Clamping in Full Term Neonates (≥ 37 Weeks) Requiring Resuscitation
Official Title
Umbilical Cord Milking Versus Immediate Cord Clamping in Full Term Neonates (≥ 37 Weeks) Requiring Resuscitation - A RANDOMIZED CONTROL TRIAL
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 5, 2022 (Actual)
Primary Completion Date
December 4, 2023 (Anticipated)
Study Completion Date
February 4, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lady Hardinge Medical College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of the study is to compare the incidence of Hypoxic ischemic encephalopathy (all stages) among singleton term neonates (≥ 37 weeks) requiring resuscitation who will undergo Umbilical cord milking as compared to Immediate cord clamping.
Detailed Description
Enrolled participants will be randomly allocated to one of two study groups: 1) Umbilical cord clamping, 2) Immediate cord clamping Umbilical cord clamping group: In the babies requiring resuscitation during vaginal delivery, the delivering obstetrician will place the infant on the mother's abdomen and about 20 cm of umbilical cord would be milked towards the infant with intact umbilical cord. The cord milking will be done four times by the obstetrical provider or by a second team member at the rate of 20 cm/2 sec. This procedure can be done in 15-20 seconds. Length of 20 cm can be estimated by the length of a sponge holding forceps which is approximately 25 cm. The umbilical cord will then clamped 2 -3 cm from the umbilical stump. Immediate cord clamping: This will occur by clamping the umbilical cord as soon as possible (average 30 seconds). Further resuscitation will be done in accordance with NRP 2015 guidelines. Stop watch will be used to calculate the duration after which the cord is clamped and cut, time to first breath, and time required to achieve HR > 100/min

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxic-Ischemic Encephalopathy, Perinatal Asphyxia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Umbilical cord milking
Arm Type
Experimental
Arm Description
20 cm of umbilical cord would be milked towards the infant with intact umbilical cord. The cord milking will be done four times. The entire procedure can be done in 15-20 seconds
Arm Title
Immediate cord clamping
Arm Type
Active Comparator
Arm Description
clamping the umbilical cord as soon as possible (average 30 seconds)
Intervention Type
Procedure
Intervention Name(s)
Umbilical cord milking
Intervention Description
20 cm of umbilical cord would be milked towards the infant with intact umbilical cord. The cord milking will be done four times. The entire procedure can be done in 15-20 seconds
Intervention Type
Procedure
Intervention Name(s)
Immediate cord clamping
Intervention Description
clamping the umbilical cord as soon as possible (average 30 seconds)
Primary Outcome Measure Information:
Title
Incidence of Hypoxic Ischemic Encephalopathy
Description
any stage as per Sarnat and Sarnat Staging
Time Frame
From date of birth until date of death from any cause whichever come first assessed till 1 week of life
Secondary Outcome Measure Information:
Title
Proportion requiring NICU admission
Description
NICU admission due to any reason
Time Frame
Till 1 week of life
Title
Level of hypoxic ischemic encephalopathy ( mild, moderate or severe)
Description
Level of hypoxic ischemic encephalopathy as per Sarnat and Sarnat Staging
Time Frame
From date of birth until date of death from any cause whichever come first assessed till 1 week of life
Title
Received blood products or saline bolus or inotropes to support blood pressure
Description
Hypotension requiring blood products or saline bolus or inotropes
Time Frame
From date of birth until date of death from any cause whichever come first assessed till 1 week of life
Title
Length of hospital stay
Description
Duration of stay in days
Time Frame
From date of birth until date of death from any cause whichever come first assessed till 4 week of life
Title
Mean Blood Pressure at 2,6,12,24,48,72 hrs
Description
Mean Blood Pressure as assessed by non-invasive oscillometric method
Time Frame
From date of birth until date of death from any cause whichever come first assessed till 72 hours of life
Title
Hyperbilirubinemia requiring phototherapy
Description
As per AAP charts
Time Frame
From date of birth until date of death from any cause whichever come first assessed till 4 week of life
Title
Proportion of neonates having APGAR score < 4 at 5 minutes of life
Description
APGAR score (Min zero maximum Ten) assessed at 1,5 minutes (Low APGAR is bad prognosis and High APGAR is good prognosis)
Time Frame
Till 5 minutes of life
Title
Neonates requiring Initial steps of resuscitation, Bag and Mask Ventilation, Intubation, chest compression and administration of drugs during resuscitation.
Description
As per NRP 2015 guidelines
Time Frame
Till 1 minutes of life
Title
Proportion of neonates developing polycythemia
Description
Polycythemia is defined as venous hematocrit >65%
Time Frame
Till first 72 hours
Title
Proportion of mortality due to any cause
Description
Including early and late neonatal deaths
Time Frame
From date of birth until date of death from any cause whichever come first assessed till 4 week of life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
37 Weeks
Maximum Age & Unit of Time
41 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Vaginally born, Singleton Term gestation (≥ 37 and & < 42 weeks), requiring resuscitation at birth Exclusion Criteria: Major congenital anomaly (antenatally diagnosed or visible at birth) Rh negative pregnancy Hydrops Abruptio Placneta/ Placenta previa Fetus with absent and reversal of End Diastolic flow Cord avulsion Refusal of consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sushma Nangia, DM (Neo)
Phone
9810838181
Email
drsnangia@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tapas Bandyopadhyay, DM (Neo)
Phone
9910371315
Email
dr.tapasbanerjee@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sushma Nangia, DM (Neo)
Organizational Affiliation
Lady Hardinge Medical College, New Delhi, India
Official's Role
Study Chair
Facility Information:
Facility Name
Lady Hardinge Medical college
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110001
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sushma Nangia, DM (Neo)
Phone
9810838181
Email
drsnangia@gmail.com
First Name & Middle Initial & Last Name & Degree
Tapas Bandyopadhyay, DM (Neo)
Phone
9910371315
First Name & Middle Initial & Last Name & Degree
Sushma Nangia, DM (Neo)
First Name & Middle Initial & Last Name & Degree
Gunjana Kumar, DM (Neo)

12. IPD Sharing Statement

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Umbilical Cord Milking Versus Immediate Cord Clamping in Full Term Neonates (≥ 37 Weeks) Requiring Resuscitation

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