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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, Katarina LU ; Sæther, Elisabeth ; Santesson, Anna LU ; Wilander, Maria LU ; Patriksson, Katarina ; Hesselman, Susanne ; Thies-Lagergren, Li LU orcid ; Rabe, Heike and Andersson, Ola LU orcid (2022) In BMC Pregnancy and Childbirth 22. p.1-13
Abstract

BACKGROUND: An 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... (More)

BACKGROUND: An 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.

METHODS: The 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 REGISTRATION: Clinicaltrials.gov, NCT04070560 . Registered 28 August 2019.

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Please use this url to cite or link to this publication:
author
; ; ; ; ; ; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Child, Preschool, Female, Health Services, Humans, Infant, Infant, Newborn, Infant, Premature, Multicenter Studies as Topic, Placenta, Pregnancy, Randomized Controlled Trials as Topic, Resuscitation, Time Factors, Umbilical Cord
in
BMC Pregnancy and Childbirth
volume
22
article number
593
pages
1 - 13
publisher
BioMed Central (BMC)
external identifiers
  • pmid:35883044
  • scopus:85134722355
ISSN
1471-2393
DOI
10.1186/s12884-022-04915-5
project
Sustained cord circulation Awaiting VEntilation
language
English
LU publication?
yes
additional info
© 2022. The Author(s).
id
b42eafb1-cb2e-40c0-9352-9b4c5cc8a905
date added to LUP
2022-08-07 10:48:38
date last changed
2024-06-25 02:38:01
@article{b42eafb1-cb2e-40c0-9352-9b4c5cc8a905,
  abstract     = {{<p>BACKGROUND: An 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.</p><p>METHODS: The 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.</p><p>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.</p><p>TRIAL REGISTRATION: Clinicaltrials.gov, NCT04070560 . Registered 28 August 2019.</p>}},
  author       = {{Ekelöf, Katarina and Sæther, Elisabeth and Santesson, Anna and Wilander, Maria and Patriksson, Katarina and Hesselman, Susanne and Thies-Lagergren, Li and Rabe, Heike and Andersson, Ola}},
  issn         = {{1471-2393}},
  keywords     = {{Child, Preschool; Female; Health Services; Humans; Infant; Infant, Newborn; Infant, Premature; Multicenter Studies as Topic; Placenta; Pregnancy; Randomized Controlled Trials as Topic; Resuscitation; Time Factors; Umbilical Cord}},
  language     = {{eng}},
  pages        = {{1--13}},
  publisher    = {{BioMed Central (BMC)}},
  series       = {{BMC Pregnancy and Childbirth}},
  title        = {{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}},
  url          = {{http://dx.doi.org/10.1186/s12884-022-04915-5}},
  doi          = {{10.1186/s12884-022-04915-5}},
  volume       = {{22}},
  year         = {{2022}},
}