The NEU-STIM Trial

NCT05942924 | Recruiting

• 1 other identifier: N22.121
• Study Type: interventional
• Target: 3,280
• Locations: 19 countries
• Sites: 43

Brief Summary

The aim of this study is to determine the effect of repetitive tactile stimulation compared to selective stimulation on oxygenation of the infant at 5 minutes after birth. Infants born before 32 weeks of gestation will be included in this trial. 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.

Conditions

Infant, Premature, Diseases; Birth, Preterm

Keywords

Preterm infant; Tactile stimulation; Resuscitation

Outcome Measures

Primary Outcomes (1)

• SpO2>80

  Proportion of infants with pre-ductal SpO2 \>80%

  At 5 minutes of life

Secondary Outcomes (16)

• Heart rate

  At 5 minutes after birth

• Number of infants who received CPAP <10min

  Within 10 minutes after birth

• Number of infants who received PPV <10min

  Within 10 minutes after birth

• Number of infants who were intubated <10min

  Within 10 minutes after birth

• Number of infants who received chest compressions <10min

  Within 10 minutes after birth

Other Outcomes (8)

• Congenital anomalies

  At birth

• Gestational age

  At birth

• Gender

  At birth

Study Arms (2)

Selective stimulation

ACTIVE COMPARATOR

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.

Procedure: Selective tactile stimulation

Repeated stimulation

EXPERIMENTAL

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.

Procedure: Repeated tactile stimulation

Interventions

Repeated tactile stimulation PROCEDURE

See arm

Repeated stimulation

Selective tactile stimulation PROCEDURE

See arm

Selective stimulation

Eligibility Criteria

• Age: Up to 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants born before 32 weeks of gestation can be included in this trial after parental consent.

Sponsors & Collaborators

• Leiden University Medical Center: lead
• European Society for Paediatric Research: collaborator

Study Sites (43)

Medical University of Graz

Graz, 8036, Austria

RECRUITING

Liège University Hospital

Liège, Belgium

RECRUITING

Clinical Hospital Center Rijeka

Rijeka, 51000, Croatia

RECRUITING

Clinical Center Split

Split, Croatia

RECRUITING

General Faculty Hospital in Prague

Prague, Czechia

RECRUITING

Institute for Mother and Child Care

Prague, Czechia

RECRUITING

Aarhus University Hospital

Aarhus, Denmark

RECRUITING

Rigshospitalet Copenhagen

Copenhagen, Denmark

RECRUITING

University Hospital Carl Gustav Carus

Dresden, Germany

RECRUITING

University Hospital Dusseldorf

Düsseldorf, Germany

RECRUITING

University Hospital Tubingen

Tübingen, Germany

RECRUITING

Aristotle University of Thessaloniki

Thessaloniki, Greece

RECRUITING

First dept of Obstetrics and Gynaecology, Semmelweis University

Budapest, Hungary

RECRUITING

Second Semmelweis University

Budapest, Hungary

RECRUITING

University of Debrecen

Debrecen, Hungary

RECRUITING

Bács-Kiskun County Teaching Hospital

Szeged, Hungary

RECRUITING

Landspitali University Hospital

Reykjavik, Iceland

RECRUITING

National Maternity Hospital

Dublin, D02 YH21, Ireland

RECRUITING

Coombe Women & Infants University Hospital

Dublin, Ireland

RECRUITING

University Hospital Galway

Galway, Ireland

RECRUITING

Ospedale dei Bambini Vittore Buzzi

Milan, Italy

RECRUITING

Leiden University Medical Center

Leiden, South Holland, 2333ZA, Netherlands

RECRUITING

Erasmus MC Sophia Kinderziekenhuis

Rotterdam, Netherlands

RECRUITING

Haukeland University Hospital

Bergen, Norway

RECRUITING

Oslo University Hospital, Ulleval

Oslo, Norway

RECRUITING

Oslo University Hospital

Oslo, Norway

RECRUITING

Stavanger University Hospital

Stavanger, Norway

RECRUITING

University Hospital of North Norway

Tromsø, Norway

RECRUITING

St Olav's Hospital Trondheim

Trondheim, Norway

RECRUITING

Jan Biziel University Hospital No. 2 in Bydgoszcz

Bydgoszcz, Poland

RECRUITING

Medical University of Gdansk

Gdansk, Poland

RECRUITING

Medical University of Silesa

Katowice, Poland

RECRUITING

University of Medical Sciences

Poznan, Poland

RECRUITING

Provincial Hospital

Rzeszów, Poland

RECRUITING

Wrocław Medical University

Wroclaw, Poland

RECRUITING

Hospital de Braga

Braga, Portugal

RECRUITING

University Ovidius of Constanta

Constanța, Romania

RECRUITING

Clinical County Emergency Hospital Sibiu

Sibiu, Romania

RECRUITING

George Emil Palade University of Medicine

Târgu Mureş, Romania

RECRUITING

La Fe University Hospital

Valencia, 46026, Spain

NOT YET RECRUITING

University of Health Sciences Sancaktepe Ilhan Varank Training and Research Hospital, Istanbul

Istanbul, Turkey (Türkiye)

RECRUITING

Bukovyna State Medical University, Chernivtsi

Chernivtsi, Ukraine

RECRUITING

Sumy State University

Sumy, Ukraine

RECRUITING

Related Publications (1)

• 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.

  PMID: 29580959 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Infant, Premature, Diseases; Premature Birth

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Janneke Dekker, PhD

CONTACT

+31715266620; j.dekker@lumc.nl

Colm O'Donnell, MD PhD

CONTACT

+35316373100; codonnell@nmh.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Centres will be randomised for the fortnight at which they will switch their tactile stimulation practice from selective stimulation to repetitive stimulation. The analysing researcher will be blinded for the allocation of treatment switch.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a stepped-wedge cluster randomised controlled trial. The participating centre, rather than the individual infant, will be the unit of randomisation.

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 12, 2023
• Study Start: March 11, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 10, 2025

Record last verified: 2025-03

Locations

NO (6); IC (1); NL (2); PT (1); UA (2); ES (1); CZ (2); DK (2); DE (3); GR (1); RO (3); IE (3); HU (4); CR (2); BE (1); IT (1); PL (6); AU (1); TU (1)