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

Primary Purpose

Asphyxia Neonatorum, Resuscitation

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Intact cord (≥ 180 seconds) resuscitation
Early (≤ 60 seconds) cord clamping
Sponsored by
Lund University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asphyxia Neonatorum focused on measuring umbilical cord

Eligibility Criteria

35 Weeks - 42 Weeks (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Hospital of HallandRecruiting
  • Skåne University HospitalRecruiting
  • Ystad hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Early (≤ 60 seconds) cord clamping

Intact cord (≥ 180 seconds) resuscitation

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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 of first cry or breathing effort
Assessed by staff present
Time of establishing spontaneous breathing
Assessed by staff present
Presence at one day of age
The place of stay for newborn at one day of age
Need of neonatal intensive care
Admission to neonatal intensive care unit
Score for Neonatal Acute Physiology (SNAP-II)
Assessed by staff at neonatal intensive care unit
Morbidity Assessment Index for Newborns (MAIN)
Assessed by staff at neonatal intensive care unit
Blood glucose
Sampled by staff at nursery of neonatal intensive care
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
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
Mortality
Death after birth
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.
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.
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.
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.
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.

Full Information

First Posted
August 26, 2019
Last Updated
June 20, 2023
Sponsor
Lund University
Collaborators
Skane University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04070560
Brief Title
Effects of Delayed Cord Clamping During Resuscitation of Newborn Near Term and Term Infants
Acronym
SAVE
Official Title
SAVE (Sustained Cord Circulation Awaiting VEntilation)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lund University
Collaborators
Skane University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asphyxia Neonatorum, Resuscitation
Keywords
umbilical cord

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early (≤ 60 seconds) cord clamping
Arm Type
Active Comparator
Arm Description
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
Arm Title
Intact cord (≥ 180 seconds) resuscitation
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Intact cord (≥ 180 seconds) resuscitation
Intervention Description
Resuscitation performed in near proximity to the mother with umbilical cord uncut
Intervention Type
Procedure
Intervention Name(s)
Early (≤ 60 seconds) cord clamping
Intervention Description
Resuscitation performed at a designated area after umbilical cord is cut
Primary Outcome Measure Information:
Title
Apgar score
Description
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
Secondary Outcome Measure Information:
Title
Apgar score
Description
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
Title
Apgar score
Description
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
Title
Time of first cry or breathing effort
Description
Assessed by staff present
Time Frame
Within 10 minutes after birth
Title
Time of establishing spontaneous breathing
Description
Assessed by staff present
Time Frame
Within 10 minutes after birth
Title
Presence at one day of age
Description
The place of stay for newborn at one day of age
Time Frame
24 hours
Title
Need of neonatal intensive care
Description
Admission to neonatal intensive care unit
Time Frame
7 days
Title
Score for Neonatal Acute Physiology (SNAP-II)
Description
Assessed by staff at neonatal intensive care unit
Time Frame
7 days
Title
Morbidity Assessment Index for Newborns (MAIN)
Description
Assessed by staff at neonatal intensive care unit
Time Frame
7 days
Title
Blood glucose
Description
Sampled by staff at nursery of neonatal intensive care
Time Frame
4 hours after birth
Title
Breathing difficulties
Description
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
Title
Breathing difficulties
Description
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
Title
Mortality
Description
Death after birth
Time Frame
One year
Title
Development
Description
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
Title
Development
Description
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
Title
Autism
Description
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
Title
Development
Description
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
Title
Motor development
Description
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
Other Pre-specified Outcome Measures:
Title
Thompson score
Description
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
Title
Thompson score
Description
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
Title
Thompson score
Description
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
Title
Thompson score
Description
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
Title
Thompson score
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Weeks
Maximum Age & Unit of Time
42 Weeks
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ola Andersson, MD PhD
Phone
+46709664180
Email
ola.andersson@med.lu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Gisela Rickle, MD PhD
Phone
+46771111 888
Email
gisela.rickle@skane.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ola Andersson, MD PhD
Organizational Affiliation
Lunds University/Skåne University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of Halland
City
Halmstad
State/Province
Halland
ZIP/Postal Code
30185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Wilander, MD
Email
maria.wilander@med.lu.se
Facility Name
Skåne University Hospital
City
Malmö
State/Province
Skåne
ZIP/Postal Code
21428
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ola Andersson, MD Phd
First Name & Middle Initial & Last Name & Degree
Johan Sandblom, MD PhD
Email
johan.sandblom@skane.se
Facility Name
Ystad hospital
City
Ystad
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camilla Jeremiasen, RNM
Email
camilla.jeremiasenkarlsson@skane.se
First Name & Middle Initial & Last Name & Degree
Anniken Björkstrand, RNM
Email
BjörAnniken.Bjorkstrand@skane.se

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in publications, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication.
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal, and that most preferably have an approval from an independent review committee.
Citations:
PubMed Identifier
24055300
Citation
Niermeyer S, Velaphi S. Promoting physiologic transition at birth: re-examining resuscitation and the timing of cord clamping. Semin Fetal Neonatal Med. 2013 Dec;18(6):385-92. doi: 10.1016/j.siny.2013.08.008. Epub 2013 Sep 19.
Results Reference
background
PubMed Identifier
28526223
Citation
Katheria AC, Brown MK, Faksh A, Hassen KO, Rich W, Lazarus D, Steen J, Daneshmand SS, Finer NN. Delayed Cord Clamping in Newborns Born at Term at Risk for Resuscitation: A Feasibility Randomized Clinical Trial. J Pediatr. 2017 Aug;187:313-317.e1. doi: 10.1016/j.jpeds.2017.04.033. Epub 2017 May 16.
Results Reference
background
PubMed Identifier
31013574
Citation
Katheria AC. Neonatal Resuscitation with an Intact Cord: Current and Ongoing Trials. Children (Basel). 2019 Apr 22;6(4):60. doi: 10.3390/children6040060. Erratum In: Children (Basel). 2019 May 21;6(5):
Results Reference
background
PubMed Identifier
31485335
Citation
Andersson O, Rana N, Ewald U, Malqvist M, Stripple G, Basnet O, Subedi K, Kc A. Intact cord resuscitation versus early cord clamping in the treatment of depressed newborn infants during the first 10 minutes of birth (Nepcord III) - a randomized clinical trial. Matern Health Neonatol Perinatol. 2019 Aug 29;5:15. doi: 10.1186/s40748-019-0110-z. eCollection 2019.
Results Reference
background
PubMed Identifier
35883044
Citation
Ekelof K, Saether E, Santesson A, Wilander M, Patriksson K, Hesselman S, Thies-Lagergren L, Rabe H, Andersson O. A hybrid type I, multi-center randomized controlled trial to study the implementation of a method for Sustained cord circulation And VEntilation (the SAVE-method) of late preterm and term neonates: a study protocol. BMC Pregnancy Childbirth. 2022 Jul 26;22(1):593. doi: 10.1186/s12884-022-04915-5.
Results Reference
background
PubMed Identifier
36646247
Citation
Wilander M, Sandblom J, Thies-Lagergren L, Andersson O, Svedenkrans J. Bilirubin Levels in Neonates >/=35 Weeks of Gestation Receiving Delayed Cord Clamping for an Extended Time-An Observational Study. J Pediatr. 2023 Jun;257:113326. doi: 10.1016/j.jpeds.2023.01.005. Epub 2023 Jan 14.
Results Reference
background
Links:
URL
http://www.savestudien.se/
Description
Official homepage

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

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