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Tactile stimulation to improve spontaneous breathing in neonatal resuscitation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27260
Enrollment
44
Registered
2016-08-04
Start date
2016-09-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

resuscitation spontaneous breathing preterm infant

Interventions

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 wi

Sponsors

Leiden University Medical Center (LUMC)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Preterm infants of 27-31+6 weeks of gestation can be randomized for receiving recurrent tactile stimulation or not.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
The main study parameter is the average respiratory minute volume at 1-4 minutes after birth (from 60 seconds until 240 seconds after birth).

Secondary

MeasureTime frame
Secondary study parameters are; o Average respiratory minute volume in the first 7 minutes after birth o Average rate of rise to maximum tidal volumes in the first 7 minutes after birth o Percentage of time of given mask ventilation o Oxygen saturation and heart rate in the first 10 minutes after birth o Maximum oxygen needed in the first 10 minutes after birth o Signs of exhaustion: a decrease in tidal volumes with lower peak inspiratory flow waves and a shift in the frequency distribution (Siew 2015). o Percentage of spontaneous breaths with tidal volumes above 4 ml/kg o Percentage of spontaneous breaths with tidal volumes above 8 ml/kg

Contacts

Public ContactJanneke Dekker

LUMC

j.dekker@lumc.nl071-5266641

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)