NCT06090968

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2022

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 13, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 19, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2024

Completed
Last Updated

July 9, 2024

Status Verified

July 1, 2024

Enrollment Period

2 years

First QC Date

October 13, 2023

Last Update Submit

July 5, 2024

Conditions

Hypoxic-Ischemic EncephalopathyPerinatal Asphyxia

Outcome Measures

Primary Outcomes (1)

  • Incidence of Hypoxic Ischemic Encephalopathy

    any stage as per Sarnat and Sarnat Staging

    From date of birth until date of death from any cause whichever come first assessed till 1 week of life

Secondary Outcomes (10)

  • Proportion requiring NICU admission

    Till 1 week of life

  • Level of hypoxic ischemic encephalopathy ( mild, moderate or severe)

    From date of birth until date of death from any cause whichever come first assessed till 1 week of life

  • Received blood products or saline bolus or inotropes to support blood pressure

    From date of birth until date of death from any cause whichever come first assessed till 1 week of life

  • Length of hospital stay

    From date of birth until date of death from any cause whichever come first assessed till 4 week of life

  • Mean Blood Pressure at 2,6,12,24,48,72 hrs

    From date of birth until date of death from any cause whichever come first assessed till 72 hours of life

  • +5 more secondary outcomes

Study Arms (2)

Umbilical cord milking

EXPERIMENTAL

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

Procedure: Umbilical cord milking

Immediate cord clamping

ACTIVE COMPARATOR

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

Procedure: Immediate cord clamping

Interventions

Umbilical cord milkingPROCEDURE

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

Umbilical cord milking
Immediate cord clampingPROCEDURE

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

Immediate cord clamping

Eligibility Criteria

Age37 Weeks - 41 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Vaginally born, Singleton Term gestation (≥ 37 and \& \< 42 weeks), requiring resuscitation at birth

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lady Hardinge Medical college

New Delhi, National Capital Territory of Delhi, 110001, India

Location

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypoxia, BrainVascular DiseasesCardiovascular DiseasesHypoxiaSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Sushma Nangia, DM (Neo)

    Lady Hardinge Medical College, New Delhi, India

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Sushma Nangia, Director Professor & Head, Department of Neonatology

Study Record Dates

First Submitted

October 13, 2023

First Posted

October 19, 2023

Study Start

February 5, 2022

Primary Completion

February 4, 2024

Study Completion

March 4, 2024

Last Updated

July 9, 2024

Record last verified: 2024-07

Locations

IN(1)