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

NCT04070560 | Active Not Recruiting

• 1 other identifier: SAVE1
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 3

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.

Conditions

Asphyxia Neonatorum; Resuscitation

Keywords

umbilical cord

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Apgar score

  At 1 minute after birth

• Apgar score

  At 10 minute after birth

• Time of first cry or breathing effort

  Within 10 minutes after birth

• Time of establishing spontaneous breathing

  Within 10 minutes after birth

• Presence at one day of age

  24 hours

Other Outcomes (5)

• Thompson score

  1 hour after birth

• Thompson score

  6 hours after birth

• Thompson score

  12 hours after birth

Study Arms (2)

Early (≤ 60 seconds) cord clamping

ACTIVE COMPARATOR

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

Intact cord (≥ 180 seconds) resuscitation

ACTIVE COMPARATOR

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

Interventions

Intact cord (≥ 180 seconds) resuscitation PROCEDURE

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

Intact cord (≥ 180 seconds) resuscitation

Early (≤ 60 seconds) cord clamping PROCEDURE

Resuscitation performed at a designated area after umbilical cord is cut

Early (≤ 60 seconds) cord clamping

Eligibility Criteria

• Age: 35 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.)
• placenta abruption / or damage to umbilical cord during childbirth (when circulation through an intact umbilical cord cannot be achieved after birth)

Sponsors & Collaborators

• Lund University: lead
• Skane University Hospital: collaborator

Study Sites (3)

Hospital of Halland

Halmstad, Halland County, 30185, Sweden

Location

Skåne University Hospital

Malmo, Skåne County, 21428, Sweden

Location

Ystad hospital

Ystad, Sweden

Location

Related Publications (6)

• 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.

  PMID: 24055300 BACKGROUND

• 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.

  PMID: 28526223 BACKGROUND

• Katheria AC. Neonatal Resuscitation with an Intact Cord: Current and Ongoing Trials. Children (Basel). 2019 Apr 22;6(4):60. doi: 10.3390/children6040060.

  PMID: 31013574 BACKGROUND

• 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.

  PMID: 31485335 BACKGROUND

• 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.

  PMID: 35883044 BACKGROUND

• 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.

  PMID: 36646247 BACKGROUND

MeSH Terms

Conditions

Asphyxia Neonatorum

Interventions

Resuscitation

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Emergency Treatment; Therapeutics

Study Officials

• Ola Andersson, MD PhD

  Lunds University/Skåne University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2019
• First Posted: August 28, 2019
• Study Start: September 30, 2019
• Primary Completion: November 30, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

SE (3)