Clinical trial NCT05942924: The NEU-STIM Trial
Official title: A Randomised Trial of Repetitive Versus Selective Tactile Stimulation for Preterm Infants at Birth: The NEU-STIM Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infant, Premature, Diseases
Birth, Preterm
Keywords: Preterm infant
Tactile stimulation
Resuscitation
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: European Society for Paediatric Research
First posted: 2023-07-12
Enrollment: 3280
Sex: ALL
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a stepped-wedge cluster randomised controlled trial. The participating centre, rather than the individual infant, will be the unit of randomisation.
Primary purpose: TREATMENT

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%.

Eligibility criteria: 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.

Primary outcomes:
measure: SpO2>80
timeFrame: At 5 minutes of life
Secondary outcomes:
measure: Heart rate
timeFrame: At 5 minutes after birth
measure: Number of infants who received CPAP <10min
timeFrame: Within 10 minutes after birth
measure: Number of infants who received PPV <10min
timeFrame: Within 10 minutes after birth
measure: Number of infants who were intubated <10min
timeFrame: Within 10 minutes after birth
measure: Number of infants who received chest compressions <10min
timeFrame: Within 10 minutes after birth
measure: Number of infants who were administered adrenaline <10min
timeFrame: Within 10 minutes after birth
measure: Number of infants who were administered volume expansion <10min
timeFrame: Within 10 minutes after birth
measure: Max FiO2
timeFrame: In the first 10 minutes after birth
measure: Death <10min
timeFrame: Within 10 minutes after birth
measure: Number of infants who were supported by CPAP in first week
timeFrame: In the first week after birth
measure: Number of infants who received surfactant in first week
timeFrame: In the first week after birth
measure: Surfactant doses
timeFrame: In the first week after birth
measure: Number of infants who were mechanically ventilated
timeFrame: In the first week after birth
measure: Number of infants with abnormalities on the first cranial ultrasound
timeFrame: In first week after birth
measure: Death
timeFrame: In the first week after birth
measure: Cord clamping time
timeFrame: During resuscitation at birth
Other outcomes:
measure: Congenital anomalies
timeFrame: At birth
measure: Gestational age
timeFrame: At birth
measure: Gender
timeFrame: At birth
measure: Mode of delivery
timeFrame: At birth
measure: Doses of antenatal steroids
timeFrame: Before birth
measure: Maternal magnesium sulphate
timeFrame: Before birth
measure: Maternal general anaesthesia
timeFrame: Before birth
measure: Complications during pregnancy
timeFrame: Before birth
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
city: Liege
country: Belgium
facility: Liège University Hospital
city: Rijeka
country: Croatia
facility: Clinical Hospital Center Rijeka
city: Split
country: Croatia
facility: Clinical Center Split
city: Prague
country: Czechia
facility: General Faculty Hospital in Prague
city: Prague
country: Czechia
facility: Institute for Mother and Child Care
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet Copenhagen
city: Dresden
country: Germany
facility: University Hospital Carl Gustav Carus
city: Dusseldorf
country: Germany
facility: University Hospital Dusseldorf
city: Tubingen
country: Germany
facility: University Hospital Tubingen
city: Thessaloniki
country: Greece
facility: Aristotle University of Thessaloniki
city: Budapest
country: Hungary
facility: First dept of Obstetrics and Gynaecology, Semmelweis University
city: Budapest
country: Hungary
facility: Second Semmelweis University
city: Debrecen
country: Hungary
facility: University of Debrecen
city: Szeged
country: Hungary
facility: Bács-Kiskun County Teaching Hospital
city: Reykjavik
country: Iceland
facility: Landspitali University Hospital
city: Dublin
country: Ireland
facility: National Maternity Hospital
city: Dublin
country: Ireland
facility: Coombe Women & Infants University Hospital
city: Galway
country: Ireland
facility: University Hospital Galway
city: Milan
country: Italy
facility: Ospedale dei Bambini Vittore Buzzi
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
state: Zuid-Holland
city: Rotterdam
country: Netherlands
facility: Erasmus MC Sophia Kinderziekenhuis
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital, Ulleval
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Stavanger
country: Norway
facility: Stavanger University Hospital
city: Tromso
country: Norway
facility: University Hospital of North Norway
city: Trondheim
country: Norway
facility: St Olav's Hospital Trondheim
city: Bydgoszcz
country: Poland
facility: Jan Biziel University Hospital No. 2 in Bydgoszcz
city: Gdańsk
country: Poland
facility: Medical University of Gdansk
city: Katowice
country: Poland
facility: Medical University of Silesa
city: Poznań
country: Poland
facility: University of Medical Sciences
city: Rzeszow
country: Poland
facility: Provincial Hospital
city: Wroclaw
country: Poland
facility: Wrocław Medical University
city: Braga
country: Portugal
facility: Hospital de Braga
city: Constanta
country: Romania
facility: University Ovidius of Constanta
city: Sibiu
country: Romania
facility: Clinical County Emergency Hospital Sibiu
city: Targu Mures
country: Romania
facility: George Emil Palade University of Medicine
city: Valencia
country: Spain
facility: La Fe University Hospital
city: Istanbul
country: Turkey
facility: University of Health Sciences Sancaktepe Ilhan Varank Training and Research Hospital, Istanbul
city: Chernivtsi
country: Ukraine
facility: Bukovyna State Medical University, Chernivtsi
city: Sumy
country: Ukraine
facility: Sumy State University
Study officials:
References:
citation: 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.