An interventional study of Intact cord (≥ 180 seconds) resuscitation and Early (≤ 60 seconds) cord clamping in Asphyxia Neonatorum and Resuscitation, sponsored by Lund University. Active, not recruiting at 3 sites in Sweden. Open to participants aged 35 Weeks to 42 Weeks. Per ClinicalTrials.gov, last updated 2025-03-17.
Sponsored by Lund University · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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
Procedure: Early (≤ 60 seconds) cord clamping
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
Procedure: Intact cord (≥ 180 seconds) resuscitation
Resuscitation performed in near proximity to the mother with umbilical cord uncut
Resuscitation performed at a designated area after umbilical cord is cut
Apgar score
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.
Time frame: At 5 minutes after birth
Apgar score
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.
Time frame: At 1 minute after birth
Apgar score
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.
Time frame: At 10 minute after birth
Time of first cry or breathing effort
Assessed by staff present
Time frame: Within 10 minutes after birth
Time of establishing spontaneous breathing
Assessed by staff present
Time frame: Within 10 minutes after birth
Presence at one day of age
The place of stay for newborn at one day of age
Time frame: 24 hours
Need of neonatal intensive care
Admission to neonatal intensive care unit
Time frame: 7 days
Score for Neonatal Acute Physiology (SNAP-II)
Assessed by staff at neonatal intensive care unit
Time frame: 7 days
Morbidity Assessment Index for Newborns (MAIN)
Assessed by staff at neonatal intensive care unit
Time frame: 7 days
Blood glucose
Sampled by staff at nursery of neonatal intensive care
Time frame: 4 hours after birth
Breathing difficulties
Respiratory rate \> 60, grunting/shallow breathing, nostril flaring, retractions between or under the ribs) Assessed by staff at nursery of neonatal intensive care
Time frame: 1 hours after birth
Breathing difficulties
Respiratory rate \> 60, grunting/shallow breathing, nostril flaring, retractions between or under the ribs) Assessed by staff at nursery of neonatal intensive care
Time frame: 6 hours after birth
Mortality
Death after birth
Time frame: One year
Development
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.
Time frame: 12 months
Development
Neurocognitive assessment by Bayley-III (alternative Bayley-IV if available). Derives a developmental quotient (DQ) three main subtests; the Cognitive Scale, the Language Scale, and the Motor Scale. Is assessed by special staff and have standardized interpretations of results.
Time frame: 24 months
Autism
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.
Time frame: 24 months
Development
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 frame: 54 months
Motor development
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.
Time frame: 54 months
Thompson score
Assessed by staff at neonatal intensive care unit. A scoring system for hypoxic ischaemic encephalopathy in predicting neurodevelopmental outcome. Minimum 0 (normal), maximum 22. A score ≥12 is associated with adverse outcomes.
Time frame: 1 hour after birth
Thompson score
Assessed by staff at neonatal intensive care unit. A scoring system for hypoxic ischaemic encephalopathy in predicting neurodevelopmental outcome. Minimum 0 (normal), maximum 22. A score ≥12 is associated with adverse outcomes.
Time frame: 6 hours after birth
Thompson score
Assessed by staff at neonatal intensive care unit. A scoring system for hypoxic ischaemic encephalopathy in predicting neurodevelopmental outcome. Minimum 0 (normal), maximum 22. A score ≥12 is associated with adverse outcomes.
Time frame: 12 hours after birth
Thompson score
Assessed by staff at neonatal intensive care unit. A scoring system for hypoxic ischaemic encephalopathy in predicting neurodevelopmental outcome. Minimum 0 (normal), maximum 22. A score ≥12 is associated with adverse outcomes.
Time frame: 24 hours after birth
Thompson score
Assessed by staff at neonatal intensive care unit. A scoring system for hypoxic ischaemic encephalopathy in predicting neurodevelopmental outcome. Minimum 0 (normal), maximum 22. A score ≥12 is associated with adverse outcomes.
Time frame: 48 hours after birth
Plan to share: Yes — Individual participant data that underlie the results reported in publications, after deidentification (text, tables, figures, and appendices).
Supporting information: Study protocol, Sap, Icf
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Lund University