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

Resuscitation Clinical Trial

— SAVE  

Official title:

SAVE (Sustained Cord Circulation Awaiting VEntilation)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04070560
• Other study ID #: SAVE1
• Status: Recruiting
• Phase: N/A
• Start date: September 30, 2019
• Est. completion date: December 31, 2026

Study information

• Verified date: June 2023
• Source: Lund University
• Contact: Ola Andersson, MD PhD
• Phone: +46709664180
• Email: ola.andersson[@]med.lu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 31, 2026
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Weeks to 42 Weeks

Eligibility

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)

Related Conditions & MeSH terms

• Asphyxia
• Asphyxia Neonatorum
• Resuscitation

Intervention

Procedure:
• Intact cord (= 180 seconds) resuscitation
Resuscitation performed in near proximity to the mother with umbilical cord uncut
• Early (= 60 seconds) cord clamping
Resuscitation performed at a designated area after umbilical cord is cut

Locations

Country	Name	City	State
Sweden	Hospital of Halland	Halmstad	Halland
Sweden	Skåne University Hospital	Malmö	Skåne
Sweden	Ystad hospital	Ystad

Sponsors (2)

Lead Sponsor	Collaborator
Lund University	Skane University Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (6)

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. — View 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. — View 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. — View 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): — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	1 hour after birth
Other	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.	6 hours after birth
Other	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.	12 hours after birth
Other	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.	24 hours after birth
Other	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.	48 hours after birth
Primary	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	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
Secondary	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
Secondary	Time of first cry or breathing effort	Assessed by staff present	Within 10 minutes after birth
Secondary	Time of establishing spontaneous breathing	Assessed by staff present	Within 10 minutes after birth
Secondary	Presence at one day of age	The place of stay for newborn at one day of age	24 hours
Secondary	Need of neonatal intensive care	Admission to neonatal intensive care unit	7 days
Secondary	Score for Neonatal Acute Physiology (SNAP-II)	Assessed by staff at neonatal intensive care unit	7 days
Secondary	Morbidity Assessment Index for Newborns (MAIN)	Assessed by staff at neonatal intensive care unit	7 days
Secondary	Blood glucose	Sampled by staff at nursery of neonatal intensive care	4 hours after birth
Secondary	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
Secondary	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
Secondary	Mortality	Death after birth	One year
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

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