Infant Death, Preterm
Conditions
Keywords
Preterm, Umbilical cord milking, Placental transfusion
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.
Interventions
PROCEDUREUmbilical cord milking
At 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.
Sponsors
Nemours Children's Clinic
Thrasher Research Fund
Thomas Jefferson University
Sharp HealthCare
Jawaharlal Nehru Medical College
Daga Memorial Maternity and Children's Hospital, Nagpur, India
Mahatma Gandhi Institute of Medical Sciences
Indira Gandhi Government Medical College & Hospital, Nagpur, India
Pimpri Chinchwad Municipal Corporation's Post-Graduate Institute, Yashwantrao Chavan Memorial Hospital, Pune, India
Government Medical College, Nagpur
Government Medical College, Chandrapur, India
Osmania Medical College, Niloufer Hospital, Hyderabad, India
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Cluster Randomized Crossover
Eligibility
Sex/Gender
ALL
Age
0 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
* Preterm infants born between 30 0/7 weeks to 34 6/7 weeks of gestation * Non-vigorous at birth
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
India
Contacts
CONTACTZubair H Aghai, MD
Outcome results
None listed