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| Name | Class |
|---|---|
| Hospital Universitario 12 de Octubre | OTHER |
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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.
Both episodes of hyperoxia and hypoxemia in preterm infants increase morbidity and mortality. Nowadays the adjustment of FiO2 is manually controlled, which means it depends on the staff, needing multiple adjustments throughout the day.
The investigators's hypothesis is that the FiO2 control by parents, improve the percentage of time in range of optimum saturation at least 10% compared to control by nurses.
The aim of this study is to compare the proportion of time with oxygen saturation (SpO2) within the assigned target range, in the preterm infants whose parents modify the fraction of inspired oxygen (FiO2) versus the nursing staff modifying group.
This is a randomized controlled clinical study in the neonatal intensive care unit at Hospital 12 de Octubre. Patients will be randomized in two groups, Experimental Group: parents controlling the saturation ranges, they will manually adjust FiO2 versus the Control Group: controlled by nursing staff (standard procedure). Saturations will be registered and adjustments of FiO2 will be filmed for nonconsecutive 20-hours periods. Twenty-three patients will be enrolled in each group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control by nursing. | Active Comparator | FiO2 adjusted manually by nursing staff. Intervention: Other. Standard procedure |
|
| Control by parents. | Experimental | FiO2 adjusted manually by parents. Intervention. Other. Experimental procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard procedure | Other | FiO2 manually controlled by nursing |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carmen R. Pallás Alonso, Dra. | Contact | 34 913908272 | carmenrosa.pallas@salud.madrid.org | |
| M. Dolores Martín Pelegrina, Dra. | Contact | 34 913908272 | mariadolores.martinp@salud.madrid.org |
| Name | Affiliation | Role |
|---|---|---|
| Carmen R. Pallás Alonso, Dra. | Hospital Universitario 12 de Octubre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29676033 | Derived | Martin-Pelegrina MD, Lorenzo-Rodriguez A, Lora-Pablos D, Munoz-Amat B, Morales-Betancourt C, Pallas-Alonso CR. FiO2 control by parents of preterm infants admitted to a neonatal intensive care unit: A pilot study. Acta Paediatr. 2018 Aug;107(8):1471-1472. doi: 10.1111/apa.14364. Epub 2018 May 11. No abstract available. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Experimental procedure |
| Other |
FiO2 manually controlled by parents, after training. |
|
| D000091642 | Urogenital Diseases |