The NEU-STIM Trial (NEU-STIM)

March 5, 2025 updated by: Janneke Dekker, Leiden University Medical Center

A Randomised Trial of Repetitive Versus Selective Tactile Stimulation for Preterm Infants At Birth: the NEU-STIM Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Rationale: A randomised study demonstrated that preterm infants who received repetitive stimulation at birth (10 second episodes of stroking of the soles of the feet and/or back, followed by 10 seconds rest) showed an increase in respiratory effort. This may in turn improve clinical outcomes as improved breathing effort may reduce the need for invasive respiratory support. Tactile stimulation can be immediately and easily performed at birth at no extra cost. It therefore has great potential to be implemented in delivery rooms (DRs) worldwide.

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%.

Study Type

Interventional

Enrollment (Estimated)

3280

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Colm O'Donnell, MD PhD
  • Phone Number: +35316373100
  • Email: codonnell@nmh.ie

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Recruiting
        • Medical University of Graz
        • Contact:
          • Nariae Baik-Schneditz, MD PhD
          • Phone Number: +433163850
        • Contact:
          • Nariae Baik-Schneditz, MD PhD
  • Belgium
      • Liege, Belgium
  • Croatia
      • Rijeka, Croatia, 51000
        • Recruiting
        • Clinical Hospital Center Rijeka
        • Contact:
          • Iva Bilic Cace, MD PhD
          • Phone Number: +38551658111
        • Contact:
          • Iva Bilić Čače, MD PhD
      • Split, Croatia
  • Czech Republic
      • Prague, Czech Republic
        • Recruiting
        • General Faculty Hospital in Prague
        • Contact:
  • Czechia
      • Prague, Czechia
  • Denmark
      • Aarhus, Denmark
        • Recruiting
        • Aarhus University Hospital
        • Contact:
          • Ulla Christensen
          • Phone Number: +45 78 45 00 00
          • Email: ullachri@rm.dk
      • Copenhagen, Denmark
  • Germany
  • Greece
      • Thessaloniki, Greece
        • Recruiting
        • Aristotle University Of Thessaloniki
        • Contact:
  • Hungary
      • Budapest, Hungary
        • Recruiting
        • First dept of Obstetrics and Gynaecology, Semmelweis University
        • Contact:
      • Budapest, Hungary
        • Recruiting
        • Second Semmelweis University
        • Contact:
      • Debrecen, Hungary
        • Recruiting
        • University of Debrecen
        • Contact:
      • Szeged, Hungary
        • Recruiting
        • Bacs-Kiskun County Teaching Hospital
        • Contact:
  • Iceland
      • Reykjavik, Iceland
        • Recruiting
        • Landspitali University Hospital
        • Contact:
  • Ireland
      • Dublin, Ireland, D02 YH21
        • Recruiting
        • National Maternity Hospital
        • Contact:
        • Contact:
          • Colm O'Donnell, MD PhD
      • Dublin, Ireland
        • Recruiting
        • Coombe Women & Infants University Hospital
        • Contact:
      • Galway, Ireland
  • Italy
  • Netherlands
      • Rotterdam, Netherlands
        • Recruiting
        • Erasmus MC Sophia Kinderziekenhuis
        • Contact:
    • Zuid-Holland
      • Leiden, Zuid-Holland, Netherlands, 2333ZA
        • Recruiting
        • Leiden University Medical Center
        • Contact:
        • Contact:
          • Janneke Dekker, PhD
  • Norway
      • Bergen, Norway
      • Oslo, Norway
      • Oslo, Norway
        • Recruiting
        • Oslo University Hospital, Ullevål
        • Contact:
      • Stavanger, Norway
      • Tromso, Norway
        • Recruiting
        • University Hospital of North Norway
        • Contact:
      • Trondheim, Norway
        • Recruiting
        • St Olav's Hospital Trondheim
        • Contact:
  • Poland
      • Bydgoszcz, Poland
      • Gdańsk, Poland
        • Recruiting
        • Medical University of Gdansk
        • Contact:
      • Katowice, Poland
        • Recruiting
        • Medical University of Silesa
        • Contact:
          • Iwona Maruniak-Chudek
          • Phone Number: +48 32 208 36 00
          • Email: ich@mp.pl
      • Poznań, Poland
        • Recruiting
        • University of Medical Sciences
        • Contact:
      • Rzeszow, Poland
        • Recruiting
        • Provincial Hospital
        • Contact:
      • Wroclaw, Poland
        • Recruiting
        • Wrocław Medical University
        • Contact:
  • Portugal
  • Romania
      • Constanta, Romania
        • Recruiting
        • University Ovidius of Constanta
        • Contact:
      • Sibiu, Romania
        • Recruiting
        • Clinical County Emergency Hospital Sibiu
        • Contact:
      • Targu Mures, Romania
        • Recruiting
        • George Emil Palade University of Medicine
        • Contact:
  • Spain
      • Valencia, Spain, 46026
        • Not yet recruiting
        • La Fe University Hospital
        • Contact:
          • Celia Barber Almenar
          • Phone Number: +34961244000
        • Contact:
          • Celia Barber Almenar
        • Contact:
          • Maximo Vento, MD PhD
  • Turkey
      • Istanbul, Turkey
        • Recruiting
        • University of Health Sciences Sancaktepe Ilhan Varank Training and Research Hospital, Istanbul
        • Contact:
  • Ukraine
      • Chernivtsi, Ukraine
        • Recruiting
        • Bukovyna State Medical University, Chernivtsi
        • Contact:
      • Sumy, Ukraine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Infants will be excluded if they are found to have a congenital abnormality or condition that has an adverse effect on breathing/ventilation or oxygenation, including: congenital diaphragmatic hernia, trachea-oesophageal fistula, cyanotic heart disease and surfactant protein deficiency. Many of the infants enrolled in the study will later be diagnosed with respiratory distress syndrome (RDS); this will not render them ineligible for inclusion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Procedure: Selective tactile stimulation
See arm
Experimental: 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.
Procedure: Repeated tactile stimulation
See arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SpO2>80
Time Frame: At 5 minutes of life
Proportion of infants with pre-ductal SpO2 >80%
At 5 minutes of life

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate
Time Frame: At 5 minutes after birth
Heart rate
At 5 minutes after birth
Number of infants who received CPAP <10min
Time Frame: Within 10 minutes after birth
Number of infants who received continuous positive airway pressure
Within 10 minutes after birth
Number of infants who received PPV <10min
Time Frame: Within 10 minutes after birth
Number of infants who received positive pressure ventilation
Within 10 minutes after birth
Number of infants who were intubated <10min
Time Frame: Within 10 minutes after birth
Number of infants who were endotracheally intubated
Within 10 minutes after birth
Number of infants who were administered adrenaline <10min
Time Frame: Within 10 minutes after birth
Adrenaline use
Within 10 minutes after birth
Max FiO2
Time Frame: In the first 10 minutes after birth
Maximum FiO2
In the first 10 minutes after birth
Number of infants who were supported by CPAP in first week
Time Frame: In the first week after birth
CPAP use in the NICU
In the first week after birth
Number of infants who received surfactant in first week
Time Frame: In the first week after birth
Surfactant administration via INSURE, LISA or ET tube
In the first week after birth
Surfactant doses
Time Frame: In the first week after birth
Number of surfactant doses administered
In the first week after birth
Number of infants with abnormalities on the first cranial ultrasound
Time Frame: In first week after birth
Abnormalities on first cranial ultrasound (IVH/PVL)
In first week after birth
Death
Time Frame: In the first week after birth
Mortality
In the first week after birth
Number of infants who received chest compressions <10min
Time Frame: Within 10 minutes after birth
Number of infants who received chest compressions <10min
Within 10 minutes after birth
Number of infants who were administered volume expansion <10min
Time Frame: Within 10 minutes after birth
Number of infants who were administered volume expansion <10minv
Within 10 minutes after birth
Death <10min
Time Frame: Within 10 minutes after birth
Death <10min
Within 10 minutes after birth
Number of infants who were mechanically ventilated
Time Frame: In the first week after birth
Mechanical ventilation
In the first week after birth
Cord clamping time
Time Frame: During resuscitation at birth
The time after birth at which the cord is clamped
During resuscitation at birth

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Congenital anomalies
Time Frame: At birth
Whether the infant has congenital anomalies, e.g. diaphragmatic hernia, oesophageal atresia, cyanotic heart disease
At birth
Gestational age
Time Frame: At birth
gestational age in weeks and days
At birth
Gender
Time Frame: At birth
Gender of the infant
At birth
Mode of delivery
Time Frame: At birth
Mode of delivery
At birth
Doses of antenatal steroids
Time Frame: Before birth
Number of doses of antenatal steroids administered
Before birth
Maternal magnesium sulphate
Time Frame: Before birth
Whether maternal magnesium sulphate was administered
Before birth
Maternal general anaesthesia
Time Frame: Before birth
Whether maternal general anaesthesia was administered
Before birth
Complications during pregnancy
Time Frame: Before birth
Whether there were any complications during pregnancy, e.g. premature prolonged rupture of membranes, chorioamnionitis, pre-eclampsia, placental abruption, twin-to-twin transfusion syndrome, hydrops fetalis, feto-maternal haemorrhage
Before birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leiden University Medical Center

Collaborators

European Society for Paediatric Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

June 30, 2023

First Submitted That Met QC Criteria

July 11, 2023

First Posted (Actual)

July 12, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 5, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N22.121

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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