The NEU-STIM Trial (NEU-STIM)
Infant, Premature, Diseases, Birth, Preterm
About this trial
This is an interventional treatment trial for Infant, Premature, Diseases focused on measuring Preterm infant, Tactile stimulation, Resuscitation
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.
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
Active Comparator
Experimental
Selective stimulation
Repeated stimulation
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.