Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries- PreTerm
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-10
SponsorNemours Children's Clinic
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Preterm infants born between 30 0/7 weeks to 34 6/7 weeks of gestation
Non-vigorous at birth
Disqualifiers
Infants with congenital malformation
Major chromosomal abnormalities
Complete placental abruption/cutting through the placenta at the time of delivery
Cord conditions (umbilical knots, inadequate cord length, cord rupture, non-reducible nuchal cord)
Trial design
Design model
Crossover
Treatments tested in this trial
Umbilical cord milking
Procedure/SurgeryAt delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. This procedure infuses a placental transfusion of blood into the infant and can be done in 1--15 seconds.
Treatment groups
800 Participants
are divided into 2 treatment groupsGroup A: Umbilical Cord MilkingActive comparator 1 intervention
Group B: Early Cord ClampingNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
In-hospital mortality
Death of a baby during birth hospitalization
Time frame
From date of birth until the date of discharge from the hospital or date of death from any cause, whichever come first, assessed up to 12 weeksSecondary outcomes
1
Hemoglobin at or after 24 hours
Hb levels
Time frame
Days 1-72
Early and late onset culture positive sepsis
Number of infants with early onset or late onset sepsis
Time frame
From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.3
Any intraventricular hemorrhage (IVH) and severe IVH (grade 3 or 4)
Number of infants with any IVH or severe IVH
Time frame
From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.4
Need for blood transfusion
Number of infants received blood transfusion
Time frame
From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Nemours Children's Clinic
Lead sponsor
Thrasher Research Fund
Collaborator
Thomas Jefferson University
Collaborator
Sharp HealthCare
Collaborator
Jawaharlal Nehru Medical College
Collaborator
Daga Memorial Maternity and Children's Hospital, Nagpur, India
Collaborator
Mahatma Gandhi Institute of Medical Sciences
Collaborator
Indira Gandhi Government Medical College & Hospital, Nagpur, India
Collaborator
Pimpri Chinchwad Municipal Corporation's Post-Graduate Institute, Yashwantrao Chavan Memorial Hospital, Pune, India
Collaborator
Government Medical College, Nagpur
Collaborator
Government Medical College, Chandrapur, India
Collaborator
Osmania Medical College, Niloufer Hospital, Hyderabad, India
Collaborator
Source ClinicalTrials.gov