Evidence map›Paper›PMID 35883044›Full record

ArticleBMC pregnancy and childbirth2022

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.

Katarina Ekelöf, Elisabeth Sæther, Anna Santesson, Maria Wilander, Katarina Patriksson, Susanne Hesselman, Li Thies-Lagergren, Heike Rabe, Ola Andersson

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC pregnancy and childbirth, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04070560 (SAVE), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
3.3field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04070560 naactive not recruitingnot on this map

SAVE (Sustained Cord Circulation Awaiting VEntilation)

TypeinterventionalSponsorLund UniversityRan2019 to 2026Enrolled600ConditionsAsphyxia Neonatorum, ResuscitationArmsIntact cord (≥ 180 seconds) resuscitation, Early (≤ 60 seconds) cord clamping
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. How Delayed Cord Clamping Saves Newborn Lives.Children (Basel, Switzerland) · 2025
    Review
  5. Article
  6. Article
  7. Article
  8. Review
  9. Article
  10. Review
  11. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 5 institutions in 3 countries.

Katarina EkelöfDepartment of Clinical Sciences Lund, Pediatrics/Neonatology, Lund University, Lund, Sweden. katarina.ekelof@med.lu.se.ORCID http://orcid.org/0000-0002-4679-4972
Elisabeth SætherDepartment of Women, Children and Adolescents, Ålesund Hospital, Møre and Romsdal Hospital Trust, Ålesund, Norway.
Anna SantessonDepartment of Clinical Sciences Lund, Child and Adolescent Psychiatry, Lund University, Lund, Sweden.
Maria WilanderDepartment of Clinical Sciences Lund, Pediatrics/Neonatology, Lund University, Lund, Sweden.
Katarina PatrikssonDepartment of Health Sciences, University West, Trollhättan, Sweden.
Susanne HesselmanDepartment of Women's and Children's Health, Uppsala University, Uppsala, Sweden.
Li Thies-LagergrenDepartment of Midwifery Research - Reproductive, Perinatal and Sexual Health, Lund University, Lund, Sweden.
Heike RabeBrighton and Sussex Medical School, University of Sussex, Brighton, UK.
Ola AnderssonDepartment of Clinical Sciences Lund, Pediatrics/Neonatology, Lund University, Lund, Sweden.
Lund University · SEÅlesund Hospital · NOBrighton and Sussex Medical School · GBUniversity West · SEUppsala University · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAn intact umbilical cord allows the physiological transfusion of blood from the placenta to the neonate, which reduces infant iron deficiency and is associated with improved development during early childhood. The implementation of delayed cord clamping practice varies depending on mode of delivery, as well as gestational age and neonatal compromise. Emerging evidence shows that infants requiring resuscitation would benefit if respiratory support were provided with the umbilical cord intact. Common barriers to providing intact cord resuscitation is the availability of neonatal resuscitation equipment close to the mother, organizational readiness for change as well as attitudes and beliefs about placental transfusion within the multidisciplinary team. Hence, clinical evaluations of cord clamping practice should include implementation outcomes in order to develop strategies for optimal cord management practice.

methodsThe Sustained cord circulation And Ventilation (SAVE) study is a hybrid type I randomized controlled study combining the evaluation of clinical outcomes with implementation and health service outcomes. In phase I of the study, a method for providing in-bed intact cord resuscitation was developed, in phase II of the study the intervention was adapted to be used in multiple settings. In phase III of the study, a full-scale multicenter study will be initiated with concurrent evaluation of clinical, implementation and health service outcomes. Clinical data on neonatal outcomes will be recorded at the labor and neonatal units. Implementation outcomes will be collected from electronic surveys sent to parents as well as staff and managers within the birth and neonatal units. Descriptive and comparative statistics and regression modelling will be used for analysis. Quantitative data will be supplemented by qualitative methods using a thematic analysis with an inductive approach. DISCUSSION: The SAVE study enables the safe development and evaluation of a method for intact cord resuscitation in a multicenter trial. The study identifies barriers and facilitators for intact cord resuscitation. The knowledge provided from the study will be of benefit for the development of cord clamping practice in different challenging clinical settings and provide evidence for development of clinical guidelines regarding optimal cord clamping.

trial registrationClinicaltrials.gov, NCT04070560 . Registered 28 August 2019.

Indexed as

Infant, PrematureResuscitationChild, PreschoolFemaleHealth ServicesHumansInfantInfant, NewbornMulticenter Studies as TopicPlacentaPregnancyRandomized Controlled Trials as TopicTime FactorsUmbilical CordDelayed cord clamping practiceImplementationIntact cord resuscitationOptimal cord managementPlacental transfusion

Identifiers

PMID35883044
PMCPMC9315331
OpenAlexW4287958845

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.