Sustained Cord Circulation at Emergency Cesarean Section
- Conditions
- Asphyxia NeonatorumFetal Hypoxia
- Interventions
- Procedure: Sustained cord (≥ 180 seconds) resuscitationProcedure: Routine (< 60 seconds) cord clamping
- Registration Number
- NCT06540222
- Lead Sponsor
- Region Skane
- 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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 1993
- 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.
- Major congenital malformation that may affect resuscitation or outcome measures.
- Major genetic disorder that may affect resuscitation or outcome measures.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intact cord Sustained cord (≥ 180 seconds) resuscitation 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 sustained cord circulation, following neonatal cardiopulmonary resuscitation guidelines. Cord clamping will be performed after respiration has been established and at the earliest after three minutes. Standard care Routine (< 60 seconds) cord clamping 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.
- Primary Outcome Measures
Name Time Method Composite outcome of admission to neonatal care for predefined criteria and death before admission. At one hour after birth Admission to neonatal care is collected from the Swedish Neonatal Quality registry (SNQ), as are criteria for admission:• Asphyxia at birth (One-, Five- and/or Ten-minute Apgar score \<4), diagnosis P21.0, P21.1A, P21.1B or P21.9.• Respiratory distress (Noted in SNQ as NAS, neonatal respiratory distress P22.8, PAS, pulmonary adaption disturbance P 22.1, RDS, respiratory distress syndrome P22.0, MAS meconium aspiration syndrome P24.0, PPHN, Persistant Pulmonary Hypertension P29.3B, or PTX, Pneumothorax P25.1).• Hypoxic-ischemic encephalopathy grade I-III, P91.6A, B, C, or X.• Hypoglycemia, P 70.4A, or B. Death of the neonate before admission is collected from Swedish pregnancy registry.
Units of measure is dichotomous, as appearance of the diagnoses or not.
- Secondary Outcome Measures
Name Time Method Respiratory distress as a diagnosis after birth One week after birth Having the at least one of the following diagnosis in the Swedish neonatal quality registry: NAS, neonatal respiratory distress P22.8, PAS, pulmonary adaption disturbance P 22.1, RDS, respiratory distress syndrome P22.0, MAS meconium aspiration syndrome P24.0, PPHN, Persistent Pulmonary Hypertension P29.3B, or PTX, Pneumothorax P25.1.
Hypoglycemia as a diagnosis after birth One week after birth Having the at least one of the following diagnosis in the Swedish neonatal quality registry: Hypoglycemia, P 70.4A, or B.
Duration of neonatal care One month Duration of neonatal care as noted in the Swedish pregnancy register and Swedish neonatal quality registry: Aggregated as day (continuous) and ≥ 2 days, dichotomous
Development assessed by ASQ at 12 months of age 12 months Assessed by Ages and Stages Questionnaire (ASQ). Minimum 0, maximum 300. Consist of 30 questions answered Yes (10), Sometimes (5), Not Yet (0). Five sub scales with six questions each: Communication, Fine motor, Gross motor, Problem solving and Personal-Social. Worse outcome is considered mean minus 2 standard deviations. 'At risk' outcome is considered mean minus 1 standard deviations.
Apgar score at 10 min 10 minutes Assessed by staff, composite of heart rate, breathing effort, skin color, muscle tone and reflexes, each sub scale 0 (absent), 1, 2 (normal). Minimum 0, maximum 10. Less than 4 is a measure for severe asphyxia, less than 7 measure of mild asphyxia.
Death after birth but before admission to neonatal unit One hour after birth Noted as dead after birth in the Swedish pregnancy register
Apgar score at 5 min 5 minutes Assessed by staff, composite of heart rate, breathing effort, skin color, muscle tone and reflexes, each sub scale 0 (absent), 1, 2 (normal). Minimum 0, maximum 10. Less than 4 is a measure for severe asphyxia, less than 7 measure of mild asphyxia.
Hypoxic-ischemic encephalopathy as a diagnosis after birth One week after birth Having the at least one of the following diagnosis in the Swedish neonatal quality registry: Hypoxic-ischemic encephalopathy grade I-III, P91.6A, B, C, or X.
Infant mortality One year Death after one hour after birth