Effects of Delayed Cord Clamping During Resuscitation of Newborn Near Term and Term Infants
- Conditions
- ResuscitationAsphyxia Neonatorum
- Interventions
- Procedure: Early (≤ 60 seconds) cord clampingProcedure: Intact cord (≥ 180 seconds) resuscitation
- Registration Number
- NCT04070560
- Lead Sponsor
- Lund University
- Brief Summary
This study evaluates resuscitation with an intact umbilical cord compared to resuscitation with the umbilical cord cut. Half of the newborn babies in need of resuscitation will be handled while having an intact umbilical cord and half will have their umbilical cord cut.
- Detailed Description
The routine procedure when a newborn baby is in need of resuscitation is to cut the umbilical cord and move the baby to a designated area for resuscitation, which can include stimulation, clearing the airways, administration of oxygen and/or positive pressure ventilation by bag and mask och T-piece resuscitator.
It has been suggested, and pilot studies has shown preliminary results, that keeping the umbilical cord intact while performing resuscitation may improve the babies outcome, by continued exchange of oxygen and carbon dioxide be the placenta and facilitating the neonatal pulmonary and circulatory transition.
Because of the limiting length of the umbilical cord, resuscitation with an intact cord must be performed in close proximity to the mother.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 600
- Pregnancy week ≥35 + 0
- Singletons
- Expected vaginal delivery
- The woman / couple can adequately assimilate information about the study
- Signed informed consent of both prospective parents
- Congenital malformation that complicates resuscitation (such as severe malformation of mouth, pharynx, respiratory system) or which causes the child not to be resuscitated due to internal structural malformations (such as more severe heart failure, diaphragm fractures, etc.)
- The child is born via acute caesarean section after inclusion and opening of study envelope
- placenta abruption / or damage to umbilical cord during childbirth (when circulation through an intact umbilical cord cannot be achieved after birth)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Early (≤ 60 seconds) cord clamping Early (≤ 60 seconds) cord clamping If the infant don't breathe, the umbilical cord is clamped (≤ 60 seconds) and cut and resuscitation will be provided at a resuscitation table Other Name: Immediate clamping Intact cord (≥ 180 seconds) resuscitation Intact cord (≥ 180 seconds) resuscitation If the infant don't breathe, the umbilical cord is not clamped and cut until after 180 seconds. Initial resuscitation will be provided bedside to the mother Other Names: Late cord clamping Deferred cord clamping Optimal cord clamping
- Primary Outcome Measures
Name Time Method Apgar score At 5 minutes after birth 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.
- Secondary Outcome Measures
Name Time Method Need of neonatal intensive care 7 days Admission to neonatal intensive care unit
Mortality One year Death after birth
Morbidity Assessment Index for Newborns (MAIN) 7 days Assessed by staff at neonatal intensive care unit
Blood glucose 4 hours after birth Sampled by staff at nursery of neonatal intensive care
Breathing difficulties 6 hours after birth Respiratory rate \> 60, grunting/shallow breathing, nostril flaring, retractions between or under the ribs) Assessed by staff at nursery of neonatal intensive care
Presence at one day of age 24 hours The place of stay for newborn at one day of age
Apgar score At 10 minute after birth 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.
Development 54 months Neurocognitive assessment by Wechsler Preschool and Primary Scale of Intelligence (WPPSI-IV). 14 subtests. The core subtests are required for the computation of the Verbal, Performance, and Full Scale intelligence quotient (IQ). Also, two other composites Processing Speed Quotient and General Language Composite.
Quotient and Composite scores have a mean of 100 and a standard deviation of 15. Subtest scaled scores have a mean of 10 and a standard deviation of 3. For Quotient and Composite score:
below 70 is Extremely Low, 70-79 is Borderline, 80-89 is Low Average, 90-109 is Average, 110-119 is High Average, 120-129 is Superior, 130+ is Very Superior.Time of first cry or breathing effort Within 10 minutes after birth Assessed by staff present
Time of establishing spontaneous breathing Within 10 minutes after birth Assessed by staff present
Score for Neonatal Acute Physiology (SNAP-II) 7 days Assessed by staff at neonatal intensive care unit
Autism 24 months Screening by Modified Checklist for Autism in Toddlers (M-CHAT). 20-question test. Answers "yes" or "no". A total score of 2 and below on the first part of the M-CHAT indicate low autism risk, a total score of 3-7 indicates medium risk and prompts administration of the follow-up form. A total score of 8 or higher indicates high autism risk.
Motor development 54 months Assessed by Movement Assessment Battery for Children (ABC). The test contains 8 tasks covering the following 3 areas: Manual Dexterity, Ball Skills, Static and Dynamic Balance. Standard scores for each domain can be compared to normative data and interpreted in terms of percentile equivalents (a) ≤5th percentile reflecting definite motor impairment, (b) ≤15th percentile reflecting borderline motor impairment, or (c) \>15th percentile reflecting no motor impairment.
Trial Locations
- Locations (3)
Hospital of Halland
🇸🇪Halmstad, Halland, Sweden
Skåne University Hospital
🇸🇪Malmö, Skåne, Sweden
Ystad hospital
🇸🇪Ystad, Sweden