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Active, Not Recruiting

NCT Number: NCT04070560

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

35 week–42 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of Halland, Halmstad, Halland County, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Intact cord (≥ 180 seconds) resuscitation

Procedure

Resuscitation performed in near proximity to the mother with umbilical cord uncut

Early (≤ 60 seconds) cord clamping

Procedure

Resuscitation performed at a designated area after umbilical cord is cut

Primary outcomes

  1. Apgar score

    Time frame: 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 outcomes

  1. Apgar score

    Time frame: At 1 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.

  2. Apgar score

    Time frame: 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.

  3. Time of first cry or breathing effort

    Time frame: Within 10 minutes after birth

    Assessed by staff present

  4. Time of establishing spontaneous breathing

    Time frame: Within 10 minutes after birth

    Assessed by staff present

  5. Presence at one day of age

    Time frame: 24 hours

    The place of stay for newborn at one day of age

  6. Need of neonatal intensive care

    Time frame: 7 days

    Admission to neonatal intensive care unit

  7. Score for Neonatal Acute Physiology (SNAP-II)

    Time frame: 7 days

    Assessed by staff at neonatal intensive care unit

  8. Morbidity Assessment Index for Newborns (MAIN)

    Time frame: 7 days

    Assessed by staff at neonatal intensive care unit

  9. Blood glucose

    Time frame: 4 hours after birth

    Sampled by staff at nursery of neonatal intensive care

  10. Breathing difficulties

    Time frame: 1 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

  11. Breathing difficulties

    Time frame: 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

  12. Mortality

    Time frame: One year

    Death after birth

  13. Development

    Time frame: 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.

  14. Development

    Time frame: 24 months

    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.

  15. Autism

    Time frame: 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.

  16. Development

    Time frame: 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.

  17. Motor development

    Time frame: 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.

Other outcomes

  1. Thompson score

    Time frame: 1 hour after birth

    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.

  2. Thompson score

    Time frame: 6 hours after birth

    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.

  3. Thompson score

    Time frame: 12 hours after birth

    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.

  4. Thompson score

    Time frame: 24 hours after birth

    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.

  5. Thompson score

    Time frame: 48 hours after birth

    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.

Sponsors and collaborators

Lead sponsor

Lund University

Other

Collaborators

  • Skane University Hospital

Registry information

Official study title

SAVE (Sustained Cord Circulation Awaiting VEntilation)

Acronym: SAVE

Important dates

Study start
2019
Primary completion
2024
Study completion
2026
First posted
Aug 28, 2019
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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