Evaluating the effects of cord milking versus clamping on infant development
A Cluster Randomized Clinical Trial of Umbilical Cord Milking Versus Early Cord Clamping on Short and Long-term Outcomes in Neonates Who Are Non-Vigorous at Birth
This study is testing whether milking the umbilical cord instead of clamping it right away can help improve the development of babies born weak at birth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3442 (estimated) |
| Ages | 22 Months to 26 Months |
| Sex | All |
| Sponsor | Nemours Children's Clinic Academic / other |
| Locations | 9 sites (Belagavi, Karnataka and 8 other locations) |
| Trial ID | NCT03682042 on ClinicalTrials.gov |
What this trial studies
This trial is an extension of the CORDMILK trial, focusing on the neurodevelopmental outcomes of term and late preterm infants who were non-vigorous at birth. It compares the effects of umbilical cord milking (UCM) and early cord clamping (ECC) on survival and neurodevelopmental impairment. The assessment will be conducted using standardized neurological and developmental tools when the infants reach 22-26 months of age.
Who should consider this trial
Good fit: Ideal candidates are infants who were enrolled in the CORDMILK trial and were non-vigorous at birth.
Not a fit: Patients who were vigorous at birth or not enrolled in the CORDMILK trial may not receive any benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve developmental outcomes for infants who are non-vigorous at birth.
How similar studies have performed: Previous studies have shown promising results with umbilical cord milking, suggesting potential benefits in similar approaches.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Enrolled in CORDMILK trial * Non-vigorous at birth Exclusion Criteria: * None
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)
- Indira Gandhi Government Medical College & Hospital — Nagpur, Maharashtra, India (Recruiting)
- Pimpri Chinchwad Municipal Corporation's Post-Graduate Institute, Yashwantrao Chavan Memorial Hospital — Pune, Maharashtra, India (Recruiting)
- Government Medical College — Chandrapur, Ms, India (Recruiting)
- Daga Memorial Woman and Children Hospital — Nagpur, Ms, India (Recruiting)
- Government Medical College and Hospital — Nagpur, Ms, India (Recruiting)
- All India Institute of Medical Science — Nagpur, Ms, India (Not_yet_recruiting)
- Mahatma Gandhi Institute of Medical Sciences/ Kasturba Hospital — Wardha, Ms, India (Recruiting)
- Sawai Man Singh (SMS) Medical College — Jaipur, Rajasthan, India (Recruiting)
Study contacts
- Principal investigator: Zubair Aghai, MD — Nemours Children's Clinic
- 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.