Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02306317
Study type Interventional
Source Hospital Universitario 12 de Octubre
Contact Carmen R. Pallás Alonso, Dra.
Phone 34 913908272
Email carmenrosa.pallas@salud.madrid.org
Status Recruiting
Phase N/A
Start date March 2014
Completion date June 2018

See also
  Status Clinical Trial Phase
Active, not recruiting NCT02452580 - The Norwegian Family Centered Care Study
Completed NCT02502916 - Enteral Feeding and Early Gut Colonization of Preterm Infants N/A
Completed NCT01748214 - Premature Infant Exposure to Noise Generated by Respiratory Support N/A
Terminated NCT02840825 - Biochip for HCMV Detection in Breast Milk
Completed NCT01354028 - Effects of Massage Therapy to Induce Sleep in Preterm Infants N/A
Completed NCT01881256 - The BabyGrow Longitudinal Study of Nutrition and Growth in Preterm Infants N/A
Completed NCT03001479 - Noninferiority Trial of Liquid Human Milk Fortifier (HMF) Hydrolyzed Protein Versus Liquid HMF With Supplemental Liquid Protein N/A
Completed NCT02788786 - Feasibility and Acceptability of Use of Daily Oral Rinse in Pregnant Women in Rural Nepal Phase 2
Completed NCT01678638 - Timing of Inguinal Hernia Repair in Premature Infants N/A
Recruiting NCT02623400 - The Effect of Perinatal Stress on the Development of Preterm Infants
Completed NCT02523222 - Prophylactic Dextrose Gel for Newborns at High-risk for Hypoglycemia N/A
Active, not recruiting NCT02508571 - Direct Swallowing Training and Oral Sensorimotor Stimulation in Preterm Infants N/A
Completed NCT02478684 - Delayed Cord Clamping in Preterm Neonates N/A
Completed NCT02477423 - A Randomized Controlled Trial Investigating if Antibiotic Use in the First 48 Hours of Life Adversely Impacts the Preterm Infant Microbiome N/A
Terminated NCT02040909 - Optimizing Propofol Dosing for (Preterm) Newborn Infants That Need Endotracheal Intubation Phase 1
Completed NCT00722943 - Neuroendocrine Mechanisms of Developmental Massage Therapy (DMT) in Preterm Infants: Clinical Study N/A
Active, not recruiting NCT02832011 - How Effect Olive Oil and Eoprotin on Immunological Parameters and Growth N/A
Completed NCT02643472 - GPS (Giving Parents Support): Parent Navigation After NICU Discharge N/A
Terminated NCT01759134 - Comparison of Post-Discharge Growth of Premature Infants Using Two Different Formulas Phase 4
Completed NCT01628510 - The Developmental Effects of NICU Positioning N/A