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ArticleTrials2024

RISEinFAMILY project: the integration of families at neonatal intensive care units (NICUs) to empower them as primary caregivers: study protocol for a stepped wedge cluster controlled trial.

M T Alferink, B Moreno-Sanz, M Cabrera-Lafuente, E Ergenekon, T R de Haan, A A M W van Kempen, J Lakhwani, H Rabe, G C Zaharie, A Pellicer and 1 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06087666 (Integrating Families at Neonatal Intensive Care Units for Empowering Them as Primary Caregivres), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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.

NCT06087666 naunknown statusnot on this map

Integrating Families at Neonatal Intensive Care Units for Empowering Them as Primary Caregivres: the Impact of the Program

TypeinterventionalSponsorInstituto de Investigación Hospital Universitario La PazRan2023 to 2024Enrolled12ConditionsPretermArmsFICare
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Article
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

11 authors.

M T AlferinkDivision of Pediatrics/Neonatology, OLVG, Location East and West, Amsterdam, The Netherlands.
B Moreno-SanzDepartment of Neonatology, La Paz University Hospital, Madrid, Spain.
M Cabrera-LafuenteDepartment of Neonatology, La Paz University Hospital, Madrid, Spain.
E ErgenekonDivision of Neonatology, Department of Pediatrics, Faculty of Medicine, Gazi University, Ankara, Turkey.
T R de HaanDivision of Neonatology, Amsterdam University Medical Centers, Amsterdam, The Netherlands.
A A M W van KempenDivision of Pediatrics/Neonatology, OLVG, Location East and West, Amsterdam, The Netherlands.
J LakhwaniDepartment of Neonatology, Women and Newborn Hospital, University Teaching Hospitals, Lusaka, Zambia.
H RabeBrighton and Sussex Medical School, and Department of Neonatology, University Hospitals Sussex, Brighton and Hove, UK.
G C ZaharieDivision of Neonatology, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca-Napoca, Romania.
A PellicerDepartment of Neonatology, La Paz University Hospital, Madrid, Spain. adelina.pellicer@salud.madrid.org.
RISEinFAMILY Consortium (European Union, MSCA-RISE-H2020)

Funding

Horizon 2020 Framework Programme 101007922
6 · The paper itself

Abstract

backgroundFamily Integrated Care (FICare) has demonstrated positive outcomes for sick neonates and has alleviated the psychological burden faced by families. FICare involves structured training for professionals and caregivers along with the provision of resources to offer physical and psychological support to parents. However, FICare implementation has been primarily limited to developed countries. It remains crucial to assess the scalability of this model in overcoming social-cultural barriers and conduct a cost-effectiveness analysis. The RISEinFAMILY project aims to develop an adapted FICare model that can serve as the international standard for neonatal care, accommodating various cultural, architectural, and socio-economic contexts.

methodsRISEinFAMILY is a pluri-cultural, stepped wedge cluster controlled trial conducted in Spain, Netherlands, the UK, Romania, Turkey, and Zambia. Eligible participants include infant-family dyads admitted to the Neonatal Intensive Care Unit (NICU) requiring specialised neonatal care for a minimum expected duration of 7 days, provided there are no comprehension barriers. Notably, this study will incorporate a value of implementation analysis on FICare, which can inform policy decisions regarding investment in implementation activities, even in situations with diverse data. DISCUSSION: This study aims to evaluate the scalability and adaptation of FICare across a broader range of geographical and sociocultural contexts and address its sustainability. Furthermore, it seeks to compare the RISEinFAMILY model with standard care, examining differences in short-term newborn outcomes, family mental health, and professional satisfaction.

trial registrationClinicalTrials.gov NCT06087666. Registered on 17 October 2023. PROTOCOL VERSION: 19 December 2022; version 2.2.

Indexed as

Infant, PrematureIntensive Care Units, NeonatalCaregiversCounselingHumansInfantInfant, NewbornParentsRandomized Controlled Trials as TopicFamily-centred roundsFamily integrated careNeonatesParent empowermentStepped wedge cluster controlled trialStress

Identifiers

PMID38594733
PMCPMC11005221

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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.