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Completed

NCT Number: NCT06090968

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

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.

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Key information

Conditions

Hypoxic-Ischemic Encephalopathy Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hypoxia Hypoxia, Brain Hypoxia-Ischemia, Brain Nervous System Diseases Pathological Conditions, Signs and Symptoms Perinatal Asphyxia Signs and Symptoms Signs and Symptoms, Respiratory Vascular Diseases

Age range

37 week–41 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lady Hardinge Medical college

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

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Umbilical Cord Milking

Procedure

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

Immediate Cord Clamping

Procedure

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

Primary outcomes

  1. Incidence of Hypoxic Ischemic Encephalopathy

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

    any stage as per Sarnat and Sarnat Staging

Secondary outcomes

  1. Proportion requiring NICU admission

    Time frame: Till 1 week of life

    NICU admission due to any reason

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

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

    Level of hypoxic ischemic encephalopathy as per Sarnat and Sarnat Staging

  3. Received blood products or saline bolus or inotropes to support blood pressure

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

    Hypotension requiring blood products or saline bolus or inotropes

  4. Length of hospital stay

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

    Duration of stay in days

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

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

    Mean Blood Pressure as assessed by non-invasive oscillometric method

  6. Hyperbilirubinemia requiring phototherapy

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

    As per AAP charts

  7. Proportion of neonates having APGAR score < 4 at 5 minutes of life

    Time frame: Till 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)

  8. Neonates requiring Initial steps of resuscitation, Bag and Mask Ventilation, Intubation, chest compression and administration of drugs during resuscitation.

    Time frame: Till 1 minutes of life

    As per NRP 2015 guidelines

  9. Proportion of neonates developing polycythemia

    Time frame: Till first 72 hours

    Polycythemia is defined as venous hematocrit >65%

  10. Proportion of mortality due to any cause

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

    Including early and late neonatal deaths

Sponsors and collaborators

Lead sponsor

Lady Hardinge Medical College

Other Gov

Registry information

Official study title

Umbilical Cord Milking Versus Immediate Cord Clamping in Full Term Neonates (≥ 37 Weeks) Requiring Resuscitation - A RANDOMIZED CONTROL TRIAL

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 19, 2023
Registry last updated
Jul 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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