The NEU-STIM Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 32
SponsorLeiden University Medical Center
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Infants born before 32 weeks of gestation can be included in this trial after parental consent.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Repeated tactile stimulation
Procedure/SurgerySee arm
Selective tactile stimulation
Procedure/SurgerySee arm
Treatment groups
3,280 Participants
are divided into 2 treatment groupsGroup A: Selective stimulationActive comparator 1 intervention
Group B: Repeated stimulationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
SpO2>80
Proportion of infants with pre-ductal SpO2 \>80%
Time frame
At 5 minutes of lifeSecondary outcomes
1
Heart rate
Heart rate
Time frame
At 5 minutes after birth2
Number of infants who received CPAP <10min
Number of infants who received continuous positive airway pressure
Time frame
Within 10 minutes after birth3
Number of infants who received PPV <10min
Number of infants who received positive pressure ventilation
Time frame
Within 10 minutes after birth4
Number of infants who were intubated <10min
Number of infants who were endotracheally intubated
Time frame
Within 10 minutes after birthOther outcomes
1
Congenital anomalies
Whether the infant has congenital anomalies, e.g. diaphragmatic hernia, oesophageal atresia, cyanotic heart disease
Time frame
At birth2
Gestational age
gestational age in weeks and days
Time frame
At birth3
Gender
Gender of the infant
Time frame
At birth4
Mode of delivery
Mode of delivery
Time frame
At birthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Leiden University Medical Center
Lead sponsor
European Society for Paediatric Research
Collaborator
Source ClinicalTrials.gov