Premature Birth of Newborn Clinical Trial
Official title:
Changing the Paradigm for Improving Neonatal Care: Clinical Study on Optimal Oxygen-saturation Time and the Adding Value of Parents to Nursing Care in the Control of Fi02
The purpose of this study is to determine whether saturation control by parents in children younger than 32 weeks or under 1500 g versus conventional care performed by nursing increases the time in which these patients remain at optimal saturation range. If the hypothesis of this study is confirmed premature infants could prevent episodes of hypoxia-hyperoxia and also give more relevance to the role of parents in caring for their children admitted in a neonatal intensive care unit.
Status | Recruiting |
Enrollment | 46 |
Est. completion date | June 2018 |
Est. primary completion date | June 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 9 Months |
Eligibility |
Inclusion Criteria: - Related to child - Preterm neonates less than 32 weeks or less than 1500 g hospitalized in the Neonatal Intensive Care Unit at Hospital 12 de Octubre. - Receiving supplemental oxygen =0.4 administered by CPAP or conventional nasal cannula or high flow or children with BiPAP (flow generator with double level pressure) - Minimum age 7 days old. - Related to the mother: - Absence of health problems that allows her to perform the task. - Availability to frequently visit her baby with the father or with a companion, at least for 20 hours, not consecutive. - Understanding of the study and the Spanish language by the mother and father or companion. - Signed informed consent. Exclusion Criteria: - Evidence of pneumothorax or pneumomediastinum. - Non-compliance with study protocol. - Requiring treatment with vasoactive drugs. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario 12 de Octubre | Madrid |
Lead Sponsor | Collaborator |
---|---|
Carmen Rosa Pallas | Hospital Universitario 12 de Octubre |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Children maintained within the saturation ranges in each group | Percentage of time the child is kept within the ranges of saturation in each group | 20-40 hours as maximum |
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