Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries- PreTerm
- Conditions
- Infant DeathPreterm
- Interventions
- Procedure: Umbilical cord milking
- Registration Number
- NCT06240715
- Lead Sponsor
- Nemours Children's Clinic
- Brief 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.
- Detailed Description
Background: Prematurity is the leading cause of death in children younger than 5 years of age. Worldwide, 15 million infants are born premature, and India alone contributes to quarter of them. Approximately 1 million children die each year due to complications of prematurity.
Delayed cord clamping (DCC), one of the methods of transfer of placental blood to neonates (placental transfusion) immediately after birth reduce mortality by 30% in premature infants. But DCC is not recommended in neonates who require immediate resuscitation. Umbilical cord milking (UCM) is an option for placental transfusion in preterm infants who require immediate resuscitation but not currently recommended due to lack of randomized clinical trials.
HYPOTHESIS: UCM will reduce the in-hospital mortality in non-vigorous preterm infants born between 30 weeks to 34 weeks of gestation compared to early cord clamping.
METHODS: This multicenter cluster crossover randomized trial will enroll approximately 800 preterm infants to early cord clamping or milking the intact cord 4 times prior to clamping.
IMPACT: If investigators find that UCM is beneficial, this simple, low-tech, no cost intervention can be used in preventing deaths in preterm infants. This trial will potentially provide evidence to support a change in guidelines making UCM part of standard practice worldwide for preterm infants who require immediate resuscitation.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 800
- Preterm infants born between 30 0/7 weeks to 34 6/7 weeks of gestation
- Non-vigorous at birth
- 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)
- Mono-chorionic twins,
- Twins with no information on amnion/chorion
- Multiple gestation >2
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Umbilical Cord Milking 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).
- Primary Outcome Measures
Name Time Method In-hospital mortality 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 weeks Death of a baby during birth hospitalization
- Secondary Outcome Measures
Name Time Method Hemoglobin at or after 24 hours Days 1-7 Hb levels
Early and late onset culture positive sepsis From date of birth until the date of discharge from the hospital, assessed up to 12 weeks. Number of infants with early onset or late onset sepsis
Any intraventricular hemorrhage (IVH) and severe IVH (grade 3 or 4) From date of birth until the date of discharge from the hospital, assessed up to 12 weeks. Number of infants with any IVH or severe IVH
Need for blood transfusion From date of birth until the date of discharge from the hospital, assessed up to 12 weeks. Number of infants received blood transfusion
Moderate to severe hypoxemic ischemic encephalopathy From date of birth until the date of discharge from the hospital, assessed up to 12 weeks. Number of infants with moderate to severe hypoxemic ischemic encephalopathy
Necrotizing enterocolitis (Bell's stage 2 or higher) From date of birth until the date of discharge from the hospital, assessed up to 12 weeks. Number of infants with necrotizing enterocolitis (Bell's stage 2 or higher)
Need for medications for hypotension From date of birth until the date of discharge from the hospital, assessed up to 12 weeks. Number of infants needed medications for hypotension
Need for phototherapy for jaundice From date of birth until the date of discharge from the hospital, assessed up to 12 weeks. Number of infants needed phototherapy for jaundice
Retinopathy of prematurity (ROP) requiring intervention From date of birth until the date of discharge from the hospital, assessed up to 12 weeks. Number of infants with ROP that required intervention
Length of hospitalization From date of birth until the date of discharge from the hospital, assessed up to 12 weeks. Number of days infants stayed in hospital
Trial Locations
- Locations (8)
Indira Gandhi Government Medical College & Hospital
🇮🇳Nagpur, Maharashtra, India
Daga Memorial Woman and Children Hospital
🇮🇳Nagpur, MS, India
Mahatma Gandhi Institute of Medical Sciences/ Kasturba Hospital
🇮🇳Wardha, MS, India
Sawai Man Singh Medical College
🇮🇳Jaipur, Rajasthan, India
KLE Academy of Higher Education and Research (Deemed-to-be-University) Jawaharlal Nehru Medical College
🇮🇳Belgaum, Karnataka, India
Government Medical College and Hospital
🇮🇳Nagpur, MS, India
Government Medical College
🇮🇳Chandrapur, Maharashtra, India
Yashwantrao Chavan Memorial Hospital
🇮🇳Pune, Maharashtra, India