NCT04070560: SAVE

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

Active, enrolled NA Last updated 17 March 2025

What this trial tests

NA trial testing Intact cord (≥ 180 seconds) resuscitation in Asphyxia Neonatorum in 600 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

30 September 2019

Primary endpoint
30 November 2024

31 December 2026

Quick facts

Lead sponsor	Lund University
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	600
Start date	30 September 2019
Primary completion	30 November 2024
Estimated completion	31 December 2026
Sites	3 locations across Sweden

Drugs / interventions tested

• Intact cord (≥ 180 seconds) resuscitation
• Early (≤ 60 seconds) cord clamping

Conditions studied

• Asphyxia Neonatorum — all drugs for Asphyxia Neonatorum →
• Resuscitation — all drugs for Resuscitation →

Sponsor

Lund University

Who can join

Adults 35 Weeks to 42 Weeks, any sex, with Asphyxia Neonatorum or Resuscitation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Ekelöf K, Sæther E, Santesson A, Wilander M, et al · · 2022 · cited 18× · PMID 35883044 · DOI 10.1186/s12884-022-04915-5
2. What does the evidence tell us? Revisiting optimal cord management at the time of birth.
   Rabe H, Mercer J, Erickson-Owens D. · · 2022 · cited 8× · PMID 35112135 · DOI 10.1007/s00431-022-04395-x
3. Cardiac Asystole at Birth Re-Visited: Effects of Acute Hypovolemic Shock.
   Mercer J, Erickson-Owens D, Rabe H, Andersson O. · · 2023 · cited 2× · PMID 36832512 · DOI 10.3390/children10020383
4. Sustained Inflation Reduces Pulmonary Blood Flow during Resuscitation with an Intact Cord.
   Nair J, Davidson L, Gugino S, Koenigsknecht C, et al · · 2021 · cited 2× · PMID 33946658 · DOI 10.3390/children8050353
5. Attitudes and beliefs regarding umbilical cord clamping among midwives, obstetricians, and neonatologists in Sweden: A national cross-sectional survey.
   Wilander M, Ekelöf K, Saether E, Berglund D, et al · · 2025 · PMID 41060969 · DOI 10.1371/journal.pone.0332745