The NEU-STIM Trial

Study Overview
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Brief Summary
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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
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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%.

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

Conditions
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Infant, Premature, Diseases, Birth, Preterm

Intervention / Treatment
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* Procedure: Repeated tactile stimulation
* Procedure: Selective tactile stimulation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 32 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Selective stimulation<br>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<br>* See arm<br>|
| Experimental: Repeated stimulation<br>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<br>* See arm<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate | Heart rate | At 5 minutes after birth | 
| Number of infants who received CPAP <10min | Number of infants who received continuous positive airway pressure | Within 10 minutes after birth | 
| Number of infants who received PPV <10min | Number of infants who received positive pressure ventilation | Within 10 minutes after birth | 
| Number of infants who were intubated <10min | Number of infants who were endotracheally intubated | Within 10 minutes after birth | 
| Number of infants who received chest compressions <10min |  | Within 10 minutes after birth | 
| Number of infants who were administered adrenaline <10min | Adrenaline use | Within 10 minutes after birth | 
| Number of infants who were administered volume expansion <10min |  | Within 10 minutes after birth | 
| Max FiO2 | Maximum FiO2 | In the first 10 minutes after birth | 
| Death <10min |  | Within 10 minutes after birth | 
| Number of infants who were supported by CPAP in first week | CPAP use in the NICU | In the first week after birth | 
| Number of infants who received surfactant in first week | Surfactant administration via INSURE, LISA or ET tube | In the first week after birth | 
| Surfactant doses | Number of surfactant doses administered | In the first week after birth | 
| Number of infants who were mechanically ventilated >12h | Mechanical ventilation for more than 12hours | In the first week after birth | 
| Number of infants with abnormalities on the first cranial ultrasound | Abnormalities on first cranial ultrasound (IVH/PVL) | In first week after birth | 
| Death | Mortality | In the first week after birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preterm infant, Tactile stimulation, Resuscitation