Sustained Cord Circulation at Emergency Cesarean Section - a New Concept for Resuscitating Neonates

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to evaluate if sustained cord circulation during resuscitation improves outcomes for term neonates born by emergency Cesarean section. The main question it aims to answer is: Does sustained cord circulation reduce admission rates to neonatal care? Researchers will compare resuscitation with an uncut umblical cord to standard resuscitation practices to see if it provides better outcomes. Participants (term neonates born by emergency Cesarean section) will: Receive resuscitation with either sustained cord circulation or standard care Be monitored for admission to neonatal care and other predefined health outcomes

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8 months
Maximum Age: 9 months
Healthy Volunteers: f
View:

• Singleton neonate

• Born alive

• Gestational age ≥37 weeks

• Born by emergency cesarean section, epidural/spinal anesthesia, where the pediatric/neonatal team has been called for to attend.

Locations
Other Locations
Sweden
Östra sjukhuset - Sahlgrenska Universitetssjukhuset
RECRUITING
Gothenburg
Hallands sjukhus, Halmstad
RECRUITING
Halmstad
Universitetssjukhuset i Linköping
RECRUITING
Linköping
Skånes Universitetssjukhus
RECRUITING
Lund
Skånes Universitetssjukhus, Malmö
RECRUITING
Malmo
Universitetssjukhuset Örebro
RECRUITING
Örebro
BB Stockholm
RECRUITING
Stockholm
Danderyds sjukhus
RECRUITING
Stockholm
Karolinska Universitetssjukhuset, Huddinge
RECRUITING
Stockholm
Karolinska Universitetssjukhuset, Solna
RECRUITING
Stockholm
Södersjukhuset - Sachsska barn- och ungdomssjukhuset
RECRUITING
Stockholm
Norrlands universitetssjukhus
RECRUITING
Umeå
Contact Information
Primary
Ola Andersson, MD PhD
ola.andersson@med.lu.se
‭+46 70-966 41 80
Backup
Jenny Svedenkrans, MD PhD
jenny.svedenkrans@ki.se
‭+46 72-469 86 60
Time Frame
Start Date: 2025-09-08
Estimated Completion Date: 2031-11
Participants
Target number of participants: 2200
Treatments
Experimental: Intact cord
The neonate will be kept close to the mother with the cord intact. When in need of ventilatory support, the neonatal team will give ventilatory support with an unclamped umbilical cord, following neonatal cardiopulmonary resuscitation guidelines. Cord clamping will be performed after respiration has been established and at the earliest after three minutes and not later than five minutes.
Active_comparator: Standard care
Management according to standard care, including immediate cord clamping for neonates requiring ventilatory support. In cases where ventilatory support is not necessary, cord clamping will be performed within 60 seconds of birth, adhering to established clinical guidelines for neonatal management.
Related Therapeutic Areas
Sponsors
Collaborators: Region Stockholm
Leads: Region Skane

This content was sourced from clinicaltrials.gov