Comparing umbilical cord milking and early cord clamping for preterm infants
A Cluster Randomized Clinical Trial of Umbilical Cord Milking Compared to Early Cord Clamping in Preterm Infants Who Are Non-vigorous at Birth
This study is testing if milking the umbilical cord instead of clamping it right away can help save the lives of preterm babies born between 30 and 34 weeks who need immediate care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 800 (estimated) |
| Ages | 0 Minutes to 10 Minutes |
| Sex | All |
| Sponsor | Nemours Children's Clinic Academic / other |
| Locations | 9 sites (Belagavi, Karnataka and 8 other locations) |
| Trial ID | NCT06240715 on ClinicalTrials.gov |
What this trial studies
This multicenter, cluster-randomized, crossover trial aims to evaluate whether umbilical cord milking (UCM) can reduce in-hospital mortality in non-vigorous preterm infants born between 30 and 34 weeks of gestation compared to early cord clamping. The study will enroll approximately 800 preterm infants and will involve milking the intact cord four times before clamping. The hypothesis is that UCM, a low-tech intervention, may provide a beneficial alternative to early cord clamping, especially for infants requiring immediate resuscitation. The findings could potentially influence global guidelines for the management of preterm infants at birth.
Who should consider this trial
Good fit: Ideal candidates for this study are non-vigorous preterm infants born between 30 and 34 weeks of gestation.
Not a fit: Patients with congenital malformations, major chromosomal abnormalities, or those requiring specific interventions due to severe complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce mortality rates in preterm infants who require immediate resuscitation.
How similar studies have performed: While delayed cord clamping has shown success in reducing mortality, umbilical cord milking is a relatively novel approach that has not been extensively tested in randomized clinical trials.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Belagavi, Karnataka and 8 other locations
- KLE Academy of Higher Education and Research (Deemed-to-be-University) Jawaharlal Nehru Medical College — Belagavi, Karnataka, India (Not_yet_recruiting)
- Government Medical College — Chandrapur, Maharashtra, India (Not_yet_recruiting)
- Indira Gandhi Government Medical College & Hospital — Nagpur, Maharashtra, India (Not_yet_recruiting)
- Yashwantrao Chavan Memorial Hospital — Pune, Maharashtra, India (Not_yet_recruiting)
- Daga Memorial Woman and Children Hospital — Nagpur, Ms, India (Recruiting)
- Government Medical College and Hospital — Nagpur, Ms, India (Not_yet_recruiting)
- Mahatma Gandhi Institute of Medical Sciences/ Kasturba Hospital — Wardha, Ms, India (Not_yet_recruiting)
- Sawai Man Singh Medical College — Jaipur, Rajasthan, India (Recruiting)
- Osmania Medical College, Niloufer Hospital — Hyderabad, Telangana, India (Recruiting)
Study contacts
- Study coordinator: Zubair H Aghai, MD
- Email: zaghai@nemours.org
- Phone: 215 955 6523
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.