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.
106 studies on the registry are indexed under Asphyxia Neonatorum; 19 are open to participants now.
This study's planned enrollment of 600 is above the median of 173 across 73 interventional studies indexed under Asphyxia Neonatorum.
Browse Asphyxia Neonatorum studies →Lund University is the lead sponsor of 234 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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, Statistical analysis plan, Informed consent form
Time frame: Beginning 9 months and ending 36 months following article publication.
Access criteria: Researchers who provide a methodologically sound proposal, and that most preferably have an approval from an independent review committee.
Ran from Sep 2019 to primary completion in Nov 2024, 62 months.
Of 33 non-industry interventional studies with no phase under Asphyxia Neonatorum, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 34. This study's 62 months is above that.
Counting every sponsor, half of 33 studies reached it within 15 months; a quarter within 8 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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