A Cluster Randomized Clinical Trial of Umbilical Cord Milking Compared to Early Cord Clamping in Preterm Infants Who Are Non-vigorous at Birth
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The goal of this multicenter, cluster-randomized, crossover trial is to determine if umbilical cord milking compared to early cord clamping will reduce in-hospital mortality in non-vigorous preterm infants born between 30 weeks and 34 weeks of gestation.
Eligibility
Participation Requirements
Sex: All
Maximum Age: Newborn
Healthy Volunteers: f
View:
• Preterm infants born between 30 0/7 weeks to 34 6/7 weeks of gestation
• Non-vigorous at birth
Locations
Other Locations
India
KLE Academy of Higher Education and Research (Deemed-to-be-University) Jawaharlal Nehru Medical College
NOT_YET_RECRUITING
Belagavi
Government Medical College
NOT_YET_RECRUITING
Chandrapur
Osmania Medical College, Niloufer Hospital
RECRUITING
Hyderabad
Sawai Man Singh Medical College
RECRUITING
Jaipur
Daga Memorial Woman and Children Hospital
RECRUITING
Nagpur
Government Medical College and Hospital
NOT_YET_RECRUITING
Nagpur
Indira Gandhi Government Medical College & Hospital
NOT_YET_RECRUITING
Nagpur
Yashwantrao Chavan Memorial Hospital
NOT_YET_RECRUITING
Pune
Mahatma Gandhi Institute of Medical Sciences/ Kasturba Hospital
NOT_YET_RECRUITING
Wardha
Contact Information
Primary
Zubair H Aghai, MD
zaghai@nemours.org
215 955 6523
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 800
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 early cord clamping (ECC).
No_intervention: Early Cord Clamping
Umbilical cord will be clamped immediately after birth (within 60 seconds)
Related Therapeutic Areas
Sponsors
Leads: Nemours Children's Clinic
Collaborators: Osmania Medical College, Niloufer Hospital, Hyderabad, India, Daga Memorial Maternity and Children's Hospital, Nagpur, India, Thrasher Research Fund, Mahatma Gandhi Institute of Medical Sciences, Wardha, India, Sharp HealthCare, Thomas Jefferson University, Government Medical College, Chandrapur, India, Pimpri Chinchwad Municipal Corporation's Post-Graduate Institute, Yashwantrao Chavan Memorial Hospital, Pune, India, Indira Gandhi Government Medical College & Hospital, Nagpur, India, Government Medical College, Nagpur, Jawaharlal Nehru Medical College