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The NEU-STIM Trial (NEU-STIM)

Primary Purpose

Infant, Premature, Diseases, Birth, Preterm

Status
Not yet recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Repeated tactile stimulation
Selective tactile stimulation
Sponsored by
Leiden University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infant, Premature, Diseases focused on measuring Preterm infant, Tactile stimulation, Resuscitation

Eligibility Criteria

undefined - 32 Weeks (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medical University of Graz
  • Clinical Hospital Center Rijeka
  • National Maternity Hospital
  • Leiden University Medical Center
  • La Fe University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Selective stimulation

Repeated stimulation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

SpO2>80
Proportion of infants with pre-ductal SpO2 >80%

Secondary Outcome Measures

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

Full Information

First Posted
June 30, 2023
Last Updated
July 11, 2023
Sponsor
Leiden University Medical Center
Collaborators
European Society for Paediatric Research
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1. Study Identification

Unique Protocol Identification Number
NCT05942924
Brief Title
The NEU-STIM Trial
Acronym
NEU-STIM
Official Title
A Randomised Trial of Repetitive Versus Selective Tactile Stimulation for Preterm Infants at Birth: The NEU-STIM Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
August 1, 2025 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Leiden University Medical Center
Collaborators
European Society for Paediatric Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Premature, Diseases, Birth, Preterm
Keywords
Preterm infant, Tactile stimulation, Resuscitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Centres will be randomised for the fortnight at which they will switch their tactile stimulation practice from selective stimulation to repetitive stimulation. The analysing researcher will be blinded for the allocation of treatment switch.
Allocation
Randomized
Enrollment
3280 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Janneke Dekker, PhD
Phone
+31715266620
Email
j.dekker@lumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Colm O'Donnell, MD PhD
Phone
+35316373100
Email
codonnell@nmh.ie
Facility Information:
Facility Name
Medical University of Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nariae Baik-Schneditz, MD PhD
Phone
+433163850
First Name & Middle Initial & Last Name & Degree
Nariae Baik-Schneditz, MD PhD
Facility Name
Clinical Hospital Center Rijeka
City
Rijeka
ZIP/Postal Code
51000
Country
Croatia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iva Bilic Cace, MD PhD
Phone
+38551658111
First Name & Middle Initial & Last Name & Degree
Iva Bilic Cace, MD PhD
Facility Name
National Maternity Hospital
City
Dublin
ZIP/Postal Code
D02 YH21
Country
Ireland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colm O'Donnell, MD PhD
Phone
+35316373100
Email
codonnell@nmh.ie
First Name & Middle Initial & Last Name & Degree
Colm O'Donnell, MD PhD
Facility Name
Leiden University Medical Center
City
Leiden
State/Province
Zuid-Holland
ZIP/Postal Code
2333ZA
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janneke Dekker, PhD
Phone
+31715266620
Email
j.dekker@lumc.nl
First Name & Middle Initial & Last Name & Degree
Janneke Dekker, PhD
Facility Name
La Fe University Hospital
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Celia Barber Almenar
Phone
+34961244000
First Name & Middle Initial & Last Name & Degree
Celia Barber Almenar
First Name & Middle Initial & Last Name & Degree
Maximo Vento, MD PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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