Comparing umbilical cord milking and early clamping for non-vigorous newborns

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 trying to see if umbilical cord milking can help non-vigorous newborns born in low-resource countries avoid serious brain problems or death compared to early clamping of the cord.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 3442 (estimated)
• Ages: 35 Weeks to 42 Weeks
• Sex: All
• Sponsor: Nemours Children's Clinic (other)
• Locations: 9 sites (Belgaum, Karnataka and 8 other locations)
• Trial ID: NCT03657394 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of umbilical cord milking (UCM) on non-vigorous infants at birth, specifically looking at its potential to reduce the incidence of moderate to severe hypoxic-ischemic encephalopathy (HIE) or death compared to early cord clamping. The research is particularly focused on low-resource countries where the incidence of HIE is significantly higher. By utilizing UCM, the study aims to enhance placental transfusion, which may provide neuroprotective benefits and improve outcomes for infants requiring immediate resuscitation. The trial will include non-vigorous neonates born between 35-42 weeks gestation and will exclude those with certain congenital conditions or complications during delivery.

Who should consider this trial

Good fit: Ideal candidates for this study are non-vigorous neonates born between 35-42 weeks of gestation.

Not a fit: Patients with congenital malformations, chromosomal abnormalities, or complications during delivery may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce mortality and improve neurodevelopmental outcomes for infants suffering from HIE in low-resource settings.

How similar studies have performed: Preliminary evidence suggests that similar approaches have shown promise, but this specific method of umbilical cord milking in low-resource settings is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Non-vigorous neonates born between 35-42 weeks

Exclusion Criteria:

* Congenital malformation of CNS.
* Chromosomal abnormalities.
* Major congenital malformations.
* Abruption/cutting through the placenta at delivery.
* Umbilical cord knots or inadequate cord length.
* Mono-chorionic twins or twins with no information on amnion/chorion.
* Multiple gestation \>2 .

Where this trial is running

Belgaum, Karnataka and 8 other locations

• KLE Academy of Higher Education and Research (Deemed-to-be-University) Jawaharlal Nehru Medical College — Belgaum, 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 H Aghai, MD — Nemours Children's Clinic
• Study coordinator: Zubair H Aghai, MD

Conditions: Hypoxic-Ischemic Encephalopathy, Birth Asphyxia, Placental transfusion