Recruiting

NEU-STIMRepetitive vs. Selective Tactile Stimulation for Preterm Infants' Oxygenation

Study Aim

This study aims to compare the effects of repetitive and selective tactile stimulation on maintaining oxygen levels above 80% in preterm infants.

What is being tested

Repeated tactile stimulation

+ Selective tactile stimulation

Procedure

Who is being recruted

Urogenital Diseases+6

+ Female Urogenital Diseases and Pregnancy Complications

+ Infant, Newborn, Diseases

+2 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: March 2024

See protocol details

Summary

Principal SponsorLeiden University Medical Center

Study ContactJanneke Dekker, PhDMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: March 11, 2024

Actual date on which the first participant was enrolled.

This study focuses on preterm infants, specifically those born before 32 weeks of gestation. The main goal is to explore how two different types of tactile stimulation at birth might affect these infants' oxygen levels. One method involves repetitive stimulation, where the baby's soles or back are gently stroked for 10 seconds, followed by a 10-second rest. The other method is selective stimulation, where clinicians only stimulate the baby if they deem it necessary. The importance of this study lies in its potential to reduce the need for invasive respiratory support in preterm infants, thereby improving their clinical outcomes. During the trial, each participating center initially follows their usual practice of selective stimulation. Later, they switch to the repetitive stimulation method. The primary measure of this study is the proportion of infants with oxygen saturation levels of 80% or more. This is evaluated through pre-ductal SpO2, a non-invasive method to monitor oxygen levels in the blood. The repetitive stimulation is performed for the first 5 minutes of life or longer if needed.

Official TitleA Randomised Trial of Repetitive Versus Selective Tactile Stimulation for Preterm Infants at Birth: The NEU-STIM Trial

NCT05942924

Principal SponsorLeiden University Medical Center

Study ContactJanneke Dekker, PhDMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

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

Design Details

3280 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsInfant, Newborn, DiseasesInfant, Premature, DiseasesObstetric Labor ComplicationsObstetric Labor, PrematureCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPregnancy ComplicationsPremature Birth

Criteria

1 inclusion criteria required to participate

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

1 exclusion criteria prevent from participating

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Newborns in this group receive gentle rubbing on the soles of their feet, back, chest, or extremities for 10 seconds, followed by 10 seconds of rest. This is repeated for the first 5 minutes after birth, or longer if needed. All other care follows international and local guidelines.

Group II

Active Comparator

In this group, newborns receive gentle touch stimulation on specific body parts if their breathing is insufficient or absent. This is done following international guidelines.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 43 locations

Recruiting

Medical University of Graz

Graz, AustriaOpen Medical University of Graz in Google Maps

Recruiting

Liège University Hospital

Liège, Belgium

Recruiting

Clinical Hospital Center Rijeka

Rijeka, Croatia

Recruiting

Clinical Center Split

Split, Croatia

Recruiting

43 Study Centers