Tactile stimulation to improve spontaneous breathing in neonatal resuscitatio
Completed
- Conditions
- Prematurity10038686preterm birth10028920
- Registration Number
- NL-OMON43256
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 44
Inclusion Criteria
Preterm infants of 27-31+6 weeks of gestation can be randomized for receiving recurrent tactile stimulation or not.
Exclusion Criteria
When an infant is included in the study, but the research protocol characterized for the allocated intervention is not strictly followed, the infant will be excluded for analysis and another infant will be included.
Infants will also be excluded if they are found to have a congenital abnormality or condition that might have an adverse effect on breathing or ventilation, including: congenital diaphragmatic hernia, trachea-oesophageal fistula or cyanotic heart disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter is the average respiratory minute volume at 1-4<br /><br>minutes after birth (from 60 seconds until 240 seconds after birth). </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary study parameters are;<br /><br>o Average respiratory minute volume in the first 7 minutes after birth<br /><br>o Average rate of rise to maximum tidal volumes in the first 7 minutes after<br /><br>birth<br /><br>o Percentage of time of given mask ventilation<br /><br>o Oxygen saturation and heart rate in the first 10 minutes after birth<br /><br>o Maximum oxygen needed in the first 10 minutes after birth<br /><br>o Signs of exhaustion: a decrease in tidal volumes with lower peak inspiratory<br /><br>flow waves and a shift in the frequency distribution (Siew 2015).<br /><br>o Percentage of spontaneous breaths with tidal volumes above 4 ml/kg<br /><br>o Percentage of spontaneous breaths with tidal volumes above 8 ml/kg</p><br>