Asphyxia Neonatorum, Fetal Hypoxia
Conditions
Keywords
Emergency cesarean section, Management umbilical cord, intact cord resuscitation
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 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
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 neonatal outcomes between two different approaches to resuscitation of term neonates born by CS; Intact cord resuscitation versus standard care with immediate cord clamping, and evaluate: A composite outcome of admission to neonatal care for predefined criteria or death before admission. Predefined criteria include asphyxia at birth, respiratory distress, hypoxic ischemic encephalopathy (HIE) and hypoglycemia. Assessed within one week after birth. 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 neonate born alive, gestational age ≥37 weeks, born by emergency cesarean section, epidural/spinal anesthesia. Pediatric team summoned before birth due to health concerns regarding the neonate. Intervention: Resuscitation with intact cord circulation during 3-5 minutes. When in need of respiratory support, the neonate will be kept close to the mother with the cord intact and the placenta attached to the uterine wall. The pediatric team will give respiratory support with sustained cord circulation, following Swedish neonatal CPR guidelines. Cord clamping will be performed after respiration has been established and at the earliest after three minutes. Cord clamping will be performed at the latest at 5 minutes. Control: Resuscitation will be performed after the cord was cut. When in need of respiratory support, the cord will be clamped immediately, and the neonate will be taken to an adjacent place for resuscitation according to Swedish neonatal CPR guidelines. Well neonates will have their cord clamped after 1 minute in accordance with national recommendations. Power analysis: At a significant level of 0.05, the power to detect the anticipated risk reduction (15%) would be 0.88 (two-sided). Study Duration 2025-2028
Interventions
PROCEDURESustained cord (≥ 180 seconds) resuscitation
Resuscitation performed in near proximity to the mother with umbilical cord uncut
PROCEDURERoutine (< 60 seconds) cord clamping
Resuscitation performed at a designated area after umbilical cord is cut
Sponsors
Region Stockholm
Region Skane
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Multicenter, stepped-wedge cluster randomized trial
Eligibility
Sex/Gender
ALL
Age
37 Weeks to 42 Weeks
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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 |
| Death after birth but before admission to neonatal unit | One hour after birth | Noted as dead after birth in the Swedish pregnancy register |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Maternal outcomes - maternal blood loss | Birth to one month | Maternal blood loss (Amount of postpartum bleeding, ml) Severe post-partum hemorrhage (\> 1000 ml and \> 2000 ml) |
| Maternal outcomes - post-surgery infection | Birth to one month | Maternal post-surgery infection Unit of measure: Diagnosis occurring in Swedish Pregnancy registry |
| Neonatal outcomes - breathing | Birth to one hour | After birth (data registered on the resuscitation chart or imported from monitor equipment): Initiation and establishment of breathing (Minutes and seconds) |
| Development | 24 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. |
| 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. |
| Neonatal outcomes - temperature | Birth to six hours | After birth (data registered on the resuscitation chart, source data sheet or imported from monitor equipment): Temperature (degrees Celsius) |
| Neonatal outcomes - interventions | Birth to one hour | After birth (data registered on the resuscitation chart or imported from monitor equipment): Rate of Interventions (e.g. ventilation, intubation, chest compressions) noted on the resuscitation chart |
| Neonatal outcomes - heart rate | Birth to 24 hours | After birth (data registered on the resuscitation chart or imported from monitor equipment): Data from Heart rate and Oxygen saturation monitoring Unit of measure: Heart rate |
| Neonatal outcomes - oxygen saturation | Birth to 24 hours | After birth (data registered on the resuscitation chart or imported from monitor equipment): Data from Heart rate and Oxygen saturation monitoring Unit of measure: Oxygen saturation |
| Neonatal outcome - hyperbilirubinemia and jaundice | Birth to seven days | Neonatal jaundice requiring phototherapy, (diagnoses reported in SPR and/or SNQ). P58.3, P59.8 (immunizations and hemolytic disorders will be excluded in this analysis) |
| Neonatal morbidity | Birth to one month | During neonatal care (diagnosis from registries): Neonatal seizures Neonatal infection Neonatal jaundice Intracranial hemorrhage Unit of measure: Diagnosis occurring in Swedish Neonatal Quality registry |
| Maternal outcomes - maternal death | Child's birth until 6 weeks | Maternal death, collected from SPR (O 95, O95.9, O97) |
Countries
Sweden
Contacts
Primary ContactOla Andersson, MD PhD
Backup ContactJenny Svedenkrans, MD PhD
Outcome results
None listed