A Cluster Randomized Clinical Trial of Umbilical Cord Milking Versus Early Cord Clamping on Short and Long-term Outcomes in Neonates Who Are Non-Vigorous at Birth
Status: Active_not_recruiting
Location: See all (9) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The investigators will conduct a study on non-vigorous infants at birth to determine if umbilical cord milking (UCM) results in lower rate of moderate to severe hypoxic ischemic encephalopathy (HIE) or death than early clamping and for infants who are non-vigorous at birth and need immediate resuscitation.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 8 months
Maximum Age: 9 months
Healthy Volunteers: f
View:
• Non-vigorous neonates born between 35-42 weeks
Locations
Other Locations
India
KLE Academy of Higher Education and Research (Deemed-to-be-University) Jawaharlal Nehru Medical College
Belagavi
Government Medical College
Chandrapur
Sawai Man Singh (SMS) Medical College
Jaipur
All India Institute of Medical Science
Nagpur
Daga Memorial Woman and Children Hospital
Nagpur
Government Medical College and Hospital
Nagpur
Indira Gandhi Government Medical College & Hospital
Nagpur
Pimpri Chinchwad Municipal Corporation's Post-Graduate Institute, Yashwantrao Chavan Memorial Hospital
Pune
Mahatma Gandhi Institute of Medical Sciences/ Kasturba Hospital
Wardha
Time Frame
Start Date: 2022-10-17
Completion Date: 2026-02-28
Participants
Target number of participants: 3442
Treatments
Active_comparator: Umbilical Cord Milking
The delivering practitioner will place the newborn below the level of the incision (at the edge of the table) at C/S and a second team member will milk the cord four times. For vaginal delivery, the delivering obstetrician, midwife or perinatal provider will hold the infant against their body or place the infant on the mother's abdomen and the cord will be milked either four times by the obstetrical provider or by a second team member. For the cord milking procedure, the obstetrical provider will milk 20-30 centimeters length of the umbilical cord over two seconds, repeating three additional times as described previously. This time is not significantly different from the time for ECC.
No_intervention: Early Cord Clamping
Umbilical cord will be clamped immediately after birth (within 60 seconds)
Authors
Related Therapeutic Areas
Sponsors
Collaborators: Jawaharlal Institute of Postgraduate Medical Education & Research, Daga Memorial Maternity and Children's Hospital, Nagpur, India, Sharp HealthCare, Pimpri Chinchwad Municipal Corporation's Post-Graduate Institute, Yashwantrao Chavan Memorial Hospital, Pune, India, Government Medical College, Nagpur, Indira Gandhi Government Medical College & Hospital, Nagpur, India, St. Louis University, University of San Diego, Jawaharlal Nehru Medical College, Karnataka Institue of Medical Sciences, Hubbali, India, All India Institute of Medical Sciences, Thomas Jefferson University, Mahatma Gandhi Institue of Medical Sciences, Wardha, India, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Leads: Nemours Children's Clinic