Nemours Children's Clinic
Zubair Aghai
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.
Preterm
Infant Death
Umbilical cord milking
NA
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.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 800 participants |
| Masking : | SINGLE |
| Primary Purpose : | PREVENTION |
| Official Title : | A Cluster Randomized Clinical Trial of Umbilical Cord Milking Compared to Early Cord Clamping in Preterm Infants Who Are Non-vigorous at Birth |
| Actual Study Start Date : | 2024-07-01 |
| Estimated Primary Completion Date : | 2026-06-30 |
| Estimated Study Completion Date : | 2026-12-30 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 0 Minutes to 10 Minutes |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
NOT YET RECRUITING
KLE Academy of Higher Education and Research (Deemed-to-be-University) Jawaharlal Nehru Medical College
Belagavi, Karnataka, India, 590010
NOT YET RECRUITING
Government Medical College
Chandrapur, Maharashtra, India, 442401
NOT YET RECRUITING
Indira Gandhi Government Medical College & Hospital
Nagpur, Maharashtra, India, 440018
NOT YET RECRUITING
Yashwantrao Chavan Memorial Hospital
Pune, Maharashtra, India, 411018
RECRUITING
Daga Memorial Woman and Children Hospital
Nagpur, MS, India, 440002
NOT YET RECRUITING
Government Medical College and Hospital
Nagpur, MS, India, 440009
NOT YET RECRUITING
Mahatma Gandhi Institute of Medical Sciences/ Kasturba Hospital
Wardha, MS, India, 442102
RECRUITING
Sawai Man Singh Medical College
Jaipur, Rajasthan, India, 302004
RECRUITING
Osmania Medical College, Niloufer Hospital
Hyderabad, Telangana, India, 500004