Study Results
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Basic Information
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RECRUITING
NA
3280 participants
INTERVENTIONAL
2024-03-11
2025-12-31
Brief Summary
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Detailed Description
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Objective: To determine the effect of repetitive tactile stimulation compared to selective stimulation on oxygenation of the infant at 5 minutes after birth.
Study design: This is a stepped-wedge cluster randomised controlled trial. The participating centre, rather than the individual infant, will be the unit of randomisation. This design is appropriate to test the effect of an intervention that encompasses a behavioral aspect - in this case the performance of tactile stimulation.
Study population: Infants born before 32 weeks of gestation will be included in this trial.
Intervention: At the start of the study, each participating centre will perform selective tactile stimulation in accordance with international guidelines, as is their usual practice. Clinicians will gently rub the back, chest, extremities or soles of the feet if they consider the breathing of the infant to be insufficient or absent. In the second stage of the study, centres will be randomised to switch their stimulation approach to repetitive stimulation. Clinicians will then gently rub the back, chest, extremities or soles of the feet for 10 seconds. To avoid extinction of the stimulatory effect (reflex), every 10 second period of stimulation will be followed by 10 seconds of rest (no stimulation). Repetitive stimulation will be performed for the first 5 minutes of life, or longer if the breathing is still considered insufficient or absent.
Main study parameter: The proportion of infants with pre-ductal oxygen saturation (SpO2) ≥ 80%.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Selective stimulation
At the start of the study, selective tactile stimulation will be performed at each participating centre in accordance with international guidelines. Clinicians will gently rub the back, chest, extremities or soles of the feet if they consider the breathing of the infant to be insufficient or absent. All other procedures in the delivery room and NICU will be performed according to international and local guidelines.
Selective tactile stimulation
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Repeated stimulation
For each centre, a lot will be drawn which indicates the month in which the protocol for tactile stimulation changes from selective stimulation to repetitive stimulation.
Repetitive stimulation is defined as gently rubbing the soles of the feet, back, chest, or extremities for 10 seconds. To prevent extinction of the stimulatory effect (reflex), every 10 second period of stimulation will be followed by 10 seconds rest (no stimulation). The repetitive stimulation will be performed for the first 5 minutes after birth, or longer if the breathing is still considered insufficient or absent. All other procedures in the delivery room and NICU will be performed according to international and local guidelines.
Repeated tactile stimulation
See arm
Interventions
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Repeated tactile stimulation
See arm
Selective tactile stimulation
See arm
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
32 Weeks
ALL
No
Sponsors
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European Society for Paediatric Research
UNKNOWN
Leiden University Medical Center
OTHER
Responsible Party
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Janneke Dekker
Principal Investigator
Locations
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Medical University of Graz
Graz, , Austria
Liège University Hospital
Liège, , Belgium
Clinical Hospital Center Rijeka
Rijeka, , Croatia
Clinical Center Split
Split, , Croatia
General Faculty Hospital in Prague
Prague, , Czechia
Institute for Mother and Child Care
Prague, , Czechia
Aarhus University Hospital
Aarhus, , Denmark
Rigshospitalet Copenhagen
Copenhagen, , Denmark
University Hospital Carl Gustav Carus
Dresden, , Germany
University Hospital Dusseldorf
Düsseldorf, , Germany
University Hospital Tubingen
Tübingen, , Germany
Aristotle University of Thessaloniki
Thessaloniki, , Greece
First dept of Obstetrics and Gynaecology, Semmelweis University
Budapest, , Hungary
Second Semmelweis University
Budapest, , Hungary
University of Debrecen
Debrecen, , Hungary
Bács-Kiskun County Teaching Hospital
Szeged, , Hungary
Landspitali University Hospital
Reykjavik, , Iceland
National Maternity Hospital
Dublin, , Ireland
Coombe Women & Infants University Hospital
Dublin, , Ireland
University Hospital Galway
Galway, , Ireland
Ospedale dei Bambini Vittore Buzzi
Milan, , Italy
Leiden University Medical Center
Leiden, South Holland, Netherlands
Erasmus MC Sophia Kinderziekenhuis
Rotterdam, , Netherlands
Haukeland University Hospital
Bergen, , Norway
Oslo University Hospital, Ulleval
Oslo, , Norway
Oslo University Hospital
Oslo, , Norway
Stavanger University Hospital
Stavanger, , Norway
University Hospital of North Norway
Tromsø, , Norway
St Olav's Hospital Trondheim
Trondheim, , Norway
Jan Biziel University Hospital No. 2 in Bydgoszcz
Bydgoszcz, , Poland
Medical University of Gdansk
Gdansk, , Poland
Medical University of Silesa
Katowice, , Poland
University of Medical Sciences
Poznan, , Poland
Provincial Hospital
Rzeszów, , Poland
Wrocław Medical University
Wroclaw, , Poland
Hospital de Braga
Braga, , Portugal
University Ovidius of Constanta
Constanța, , Romania
Clinical County Emergency Hospital Sibiu
Sibiu, , Romania
George Emil Palade University of Medicine
Târgu Mureş, , Romania
La Fe University Hospital
Valencia, , Spain
University of Health Sciences Sancaktepe Ilhan Varank Training and Research Hospital, Istanbul
Istanbul, , Turkey (Türkiye)
Bukovyna State Medical University, Chernivtsi
Chernivtsi, , Ukraine
Sumy State University
Sumy, , Ukraine
Countries
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Central Contacts
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Facility Contacts
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Nariae Baik-Schneditz, MD PhD
Role: primary
Iva Bilic Cace, MD PhD
Role: primary
Celia Barber Almenar
Role: primary
References
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Dekker J, Hooper SB, Martherus T, Cramer SJE, van Geloven N, Te Pas AB. Repetitive versus standard tactile stimulation of preterm infants at birth - A randomized controlled trial. Resuscitation. 2018 Jun;127:37-43. doi: 10.1016/j.resuscitation.2018.03.030. Epub 2018 Mar 23.
Related Links
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Related Info
Other Identifiers
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N22.121
Identifier Type: -
Identifier Source: org_study_id
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