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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04070560
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : September 14, 2021
Sponsor:
Collaborator:
Skane University Hospital
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Asphyxia Neonatorum Resuscitation Procedure: Intact cord (≥ 180 seconds) resuscitation Procedure: Early (≤ 60 seconds) cord clamping Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: SAVE (Sustained Cord Circulation Awaiting VEntilation)
Actual Study Start Date : September 30, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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
Procedure: Early (≤ 60 seconds) cord clamping
Resuscitation performed at a designated area after umbilical cord is cut

Active Comparator: 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

Procedure: Intact cord (≥ 180 seconds) resuscitation
Resuscitation performed in near proximity to the mother with umbilical cord uncut




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Weeks to 42 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04070560


Contacts
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Contact: Ola Andersson, MD PhD +46709664180 ola.andersson@med.lu.se
Contact: Gisela Rickle, MD PhD +46771111 888 gisela.rickle@skane.se

Locations
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Sweden
Hospital of Halland Recruiting
Halmstad, Halland, Sweden, 30185
Contact: Maria Wilander, MD       maria.wilander@med.lu.se   
Skåne University Hospital Recruiting
Malmö, Skåne, Sweden, 21428
Contact: Ola Andersson, MD Phd         
Contact: Johan Sandblom, MD PhD       johan.sandblom@skane.se   
Ystad hospital Recruiting
Ystad, Sweden
Contact: Camilla Jeremiasen, RNM       camilla.jeremiasenkarlsson@skane.se   
Contact: Anniken Björkstrand, RNM       BjörAnniken.Bjorkstrand@skane.se   
Sponsors and Collaborators
Lund University
Skane University Hospital
Investigators
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Principal Investigator: Ola Andersson, MD PhD Lunds University/Skåne University Hospital
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lund University
ClinicalTrials.gov Identifier: NCT04070560    
Other Study ID Numbers: SAVE1
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: September 14, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in publications, after deidentification (text, tables, figures, and appendices).
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lund University:
umbilical cord
Additional relevant MeSH terms:
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Asphyxia Neonatorum
Asphyxia
Death
Pathologic Processes
Wounds and Injuries
Infant, Newborn, Diseases