Clinical trial NCT06540222: Sustained Cord Circulation at Emergency Cesarean Section
Official title: Sustained Cord Circulation at Emergency Cesarean Section - a New Concept for Resuscitating Neonates
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Asphyxia Neonatorum
Fetal Hypoxia
Keywords: Emergency cesarean section
Management umbilical cord
intact cord resuscitation
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 1993
Sex: ALL
Minimum age (years): 37
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, stepped-wedge cluster randomized trial
Primary purpose: TREATMENT

Brief 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 sustained cord circulation 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

Detailed description: Study Title

Sustained Cord Circulation During Resuscitation of Non-Breathing Neonates Born by Cesarean Section: A Multicenter Randomized Controlled Trial

Primary Objectives:

To compare sustained cord circulation during resuscitation with standard care for term neonates born by emergency Cesarean section, and evaluate:

A composite outcome of admission to neonatal care for predefined criteria (asphyxia at birth, respiratory distress, hypoxic-ischemic encephalopathy, hypoglycemia) and death before admission.

Secondary Objectives: Secondary outcomes will include short and long-term neonatal outcomes, adverse maternal and neonatal outcomes, and caregivers' and staff's experiences.

Study Design: A multicenter, stepped-wedge cluster randomized trial.

Study Population: Singleton term neonates born alive, gestational age ≥37 weeks, by emergency Cesarean section with epidural/spinal anesthesia, where the pediatric/neonatal team has been called to attend.

Intervention: Neonates will be kept close to the mother with the cord intact. When in need of ventilatory support, the neonatal team will give respiratory support with sustained cord circulation, following neonatal cardiopulmonary resuscitation (CPR) guidelines. Cord clamping will be performed after respiration has been established and at the earliest after three minutes.

Control: Management according to standard care, including immediate cord clamping for neonates requiring ventilatory support. In cases where ventilatory assistance is not necessary, cord clamping will be performed within 60 seconds of birth, adhering to established clinical guidelines for neonatal management.

Power analysis: With significance level 0.05, the power to detect the anticipated risk reduction (50%) would be \>0.85.

Study Duration 2025-2028

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Major congenital malformation that may affect resuscitation or outcome measures.
* Major genetic disorder that may affect resuscitation or outcome measures.

Primary outcomes:
measure: Composite outcome of admission to neonatal care for predefined criteria and death before admission.
timeFrame: At one hour after birth
Secondary outcomes:
measure: Apgar score at 5 min
timeFrame: 5 minutes
measure: Apgar score at 10 min
timeFrame: 10 minutes
measure: Respiratory distress as a diagnosis after birth
timeFrame: One week after birth
measure: Hypoxic-ischemic encephalopathy as a diagnosis after birth
timeFrame: One week after birth
measure: Hypoglycemia as a diagnosis after birth
timeFrame: One week after birth
measure: Duration of neonatal care
timeFrame: One month
measure: Death after birth but before admission to neonatal unit
timeFrame: One hour after birth
measure: Infant mortality
timeFrame: One year
measure: Development assessed by ASQ at 12 months of age
timeFrame: 12 months
Other outcomes:
measure: Neonatal outcomes - breathing
timeFrame: Birth to one hour
measure: Neonatal outcomes - temperature
timeFrame: Birth to six hours
measure: Neonatal outcomes - interventions
timeFrame: Birth to one hour
measure: Neonatal outcomes - heart rate
timeFrame: Birth to 24 hours
measure: Neonatal outcomes - oxygen saturation
timeFrame: Birth to 24 hours
measure: Neonatal morbidity
timeFrame: Birth to one month
measure: Maternal outcomes - maternal blood loss
timeFrame: Birth to one month
measure: Maternal outcomes
timeFrame: Birth to one month
measure: Development
timeFrame: 24 months
measure: Development
timeFrame: 36 months
measure: Development
timeFrame: 48 months
Locations:
Study officials:
affiliation: Region skåne, Lund University
name: Ola Andersson, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alikhani VS, Thies-Lagergren L, Svedenkrans J, Elfvin A, Bolk J, Andersson O. Stabilisation and resuscitation with intact cord circulation is feasible using a wide variety of approaches; a scoping review. Acta Paediatr. 2023 Dec;112(12):2468-2477. doi: 10.1111/apa.16985. Epub 2023 Sep 28.