The NEU-STIM Trial
- Conditions
- Infant, Premature, DiseasesBirth, Preterm
- Interventions
- Procedure: Selective tactile stimulationProcedure: Repeated tactile stimulation
- Registration Number
- NCT05942924
- Lead Sponsor
- Leiden University Medical Center
- 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.
- 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%.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 3280
- Infants born before 32 weeks of gestation can be included in this trial after parental consent.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Selective stimulation Selective tactile 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. Repeated stimulation Repeated tactile 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.
- Primary Outcome Measures
Name Time Method SpO2>80 At 5 minutes of life Proportion of infants with pre-ductal SpO2 \>80%
- Secondary Outcome Measures
Name Time Method Heart rate At 5 minutes after birth Heart rate
Number of infants who received CPAP <10min Within 10 minutes after birth Number of infants who received continuous positive airway pressure
Number of infants who received PPV <10min Within 10 minutes after birth Number of infants who received positive pressure ventilation
Death <10min Within 10 minutes after birth Death \<10min
Number of infants who were intubated <10min Within 10 minutes after birth Number of infants who were endotracheally intubated
Number of infants who received chest compressions <10min Within 10 minutes after birth Number of infants who received chest compressions \<10min
Number of infants who were administered adrenaline <10min Within 10 minutes after birth Adrenaline use
Number of infants who were administered volume expansion <10min Within 10 minutes after birth Number of infants who were administered volume expansion \<10minv
Death In the first week after birth Mortality
Max FiO2 In the first 10 minutes after birth Maximum FiO2
Number of infants who were supported by CPAP in first week In the first week after birth CPAP use in the NICU
Number of infants who received surfactant in first week In the first week after birth Surfactant administration via INSURE, LISA or ET tube
Surfactant doses In the first week after birth Number of surfactant doses administered
Number of infants who were mechanically ventilated In the first week after birth Mechanical ventilation
Number of infants with abnormalities on the first cranial ultrasound In first week after birth Abnormalities on first cranial ultrasound (IVH/PVL)
Cord clamping time During resuscitation at birth The time after birth at which the cord is clamped
Trial Locations
- Locations (43)
Liège University Hospital
🇧🇪Liege, Belgium
Clinical Center Split
🇭🇷Split, Croatia
General Faculty Hospital in Prague
🇨🇿Prague, Czech Republic
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
🇩🇪Dusseldorf, Germany
University Hospital Tubingen
🇩🇪Tubingen, 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
Coombe Women & Infants University Hospital
🇮🇪Dublin, Ireland
University Hospital Galway
🇮🇪Galway, Ireland
Ospedale dei Bambini Vittore Buzzi
🇮🇹Milan, Italy
Erasmus MC Sophia Kinderziekenhuis
🇳🇱Rotterdam, Netherlands
Haukeland University Hospital
🇳🇴Bergen, Norway
Oslo University Hospital, Ulleval
🇳🇴Oslo, Norway
Oslo University Hospital
🇳🇴Oslo, Norway
Jan Biziel University Hospital No. 2 in Bydgoszcz
🇵🇱Bydgoszcz, Poland
University of Medical Sciences
🇵🇱Poznań, Poland
Provincial Hospital
🇵🇱Rzeszow, Poland
Wrocław Medical University
🇵🇱Wroclaw, Poland
Hospital de Braga
🇵🇹Braga, Portugal
University Ovidius of Constanta
🇷🇴Constanta, Romania
Clinical County Emergency Hospital Sibiu
🇷🇴Sibiu, Romania
George Emil Palade University of Medicine
🇷🇴Targu Mures, Romania
University of Health Sciences Sancaktepe Ilhan Varank Training and Research Hospital, Istanbul
🇹🇷Istanbul, Turkey
Stavanger University Hospital
🇳🇴Stavanger, Norway
St Olav's Hospital Trondheim
🇳🇴Trondheim, Norway
University Hospital of North Norway
🇳🇴Tromso, Norway
Medical University of Gdansk
🇵🇱Gdańsk, Poland
Medical University of Silesa
🇵🇱Katowice, Poland
Bukovyna State Medical University, Chernivtsi
🇺🇦Chernivtsi, Ukraine
Sumy State University
🇺🇦Sumy, Ukraine
Medical University of Graz
🇦🇹Graz, Austria
Clinical Hospital Center Rijeka
🇭🇷Rijeka, Croatia
National Maternity Hospital
🇮🇪Dublin, Ireland
Leiden University Medical Center
🇳🇱Leiden, Zuid-Holland, Netherlands
La Fe University Hospital
🇪🇸Valencia, Spain