The NEU-STIM Trial

Infant, Premature, Diseases Clinical Trial

— NEU-STIM  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05942924
• Other study ID #: N22.121
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: September 1, 2025

Study information

• Verified date: July 2023
• Source: Leiden University Medical Center
• Contact: Janneke Dekker, PhD
• Phone: +31715266620
• Email: j.dekker[@]lumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 3280
• Est. completion date: September 1, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 32 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Birth, Preterm
• Infant, Premature, Diseases
• Premature Birth

Intervention

Procedure:
• Repeated tactile stimulation
See arm
• Selective tactile stimulation
See arm

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz
Croatia	Clinical Hospital Center Rijeka	Rijeka
Ireland	National Maternity Hospital	Dublin
Netherlands	Leiden University Medical Center	Leiden	Zuid-Holland
Spain	La Fe University Hospital	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Leiden University Medical Center	European Society for Paediatric Research

Countries where clinical trial is conducted

Austria,  Croatia,  Ireland,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SpO2>80	Proportion of infants with pre-ductal SpO2 >80%	At 5 minutes of life
Secondary	Heart rate	Heart rate	At 5 minutes after birth
Secondary	Number of infants who received CPAP <10min	Number of infants who received continuous positive airway pressure	Within 10 minutes after birth
Secondary	Number of infants who received PPV <10min	Number of infants who received positive pressure ventilation	Within 10 minutes after birth
Secondary	Number of infants who were intubated <10min	Number of infants who were endotracheally intubated	Within 10 minutes after birth
Secondary	Number of infants who received chest compressions <10min		Within 10 minutes after birth
Secondary	Number of infants who were administered adrenaline <10min	Adrenaline use	Within 10 minutes after birth
Secondary	Number of infants who were administered volume expansion <10min		Within 10 minutes after birth
Secondary	Max FiO2	Maximum FiO2	In the first 10 minutes after birth
Secondary	Death <10min		Within 10 minutes after birth
Secondary	Number of infants who were supported by CPAP in first week	CPAP use in the NICU	In the first week after birth
Secondary	Number of infants who received surfactant in first week	Surfactant administration via INSURE, LISA or ET tube	In the first week after birth
Secondary	Surfactant doses	Number of surfactant doses administered	In the first week after birth
Secondary	Number of infants who were mechanically ventilated >12h	Mechanical ventilation for more than 12hours	In the first week after birth
Secondary	Number of infants with abnormalities on the first cranial ultrasound	Abnormalities on first cranial ultrasound (IVH/PVL)	In first week after birth
Secondary	Death	Mortality	In the first week after birth