Effects of Delayed Cord Clamping During Resuscitation of Newborn Near Term and Term Infants

Study Overview
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Brief Summary
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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
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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.

Official Title
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SAVE (Sustained Cord Circulation Awaiting VEntilation)

Conditions
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Asphyxia Neonatorum, Resuscitation

Intervention / Treatment
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* Procedure: Intact cord (≥ 180 seconds) resuscitation
* Procedure: Early (≤ 60 seconds) cord clamping


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 35 Weeks
Maximum Age: 42 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early (≤ 60 seconds) cord clamping<br>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<br>* Resuscitation performed at a designated area after umbilical cord is cut<br>|
| Active Comparator: Intact cord (≥ 180 seconds) resuscitation<br>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<br>* Resuscitation performed in near proximity to the mother with umbilical cord uncut<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At 5 minutes after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | At 10 minute after birth | 
| Time of first cry or breathing effort | Assessed by staff present | Within 10 minutes after birth | 
| Time of establishing spontaneous breathing | Assessed by staff present | Within 10 minutes after birth | 
| Presence at one day of age | The place of stay for newborn at one day of age | 24 hours | 
| Need of neonatal intensive care | Admission to neonatal intensive care unit | 7 days | 
| Score for Neonatal Acute Physiology (SNAP-II) | Assessed by staff at neonatal intensive care unit | 7 days | 
| Morbidity Assessment Index for Newborns (MAIN) | Assessed by staff at neonatal intensive care unit | 7 days | 
| Blood glucose | Sampled by staff at nursery of neonatal intensive care | 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 | 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 | 6 hours after birth | 
| Mortality | Death after birth | 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. | 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. | 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. | 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. | 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. | 54 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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umbilical cord