Effects of Mother Position in Skin-to-skin Contact Newborn on Oxygen Saturation Levels.
- Conditions
- Neonatal Disorder
- Interventions
- Other: Head-of-bed elevated 45°Other: Head-of-bed elevated 15°
- Registration Number
- NCT02585492
- Lead Sponsor
- Red Salud Materno Infantil y del Desarrollo
- Brief Summary
The purpose of this study is to determine if the position of the mother in the first two hours after delivery, while she is in skin to skin contact with your child, influences the oxygen saturation and/or heart rate of the newborn. In this way it could provide some useful information for the prevention of seemingly lethal episodes or sudden death of the child when, following current recommendations is skin to skin contact in the first hours of life. These episodes are communicating in all developed countries and have caused great concern and interest in the scientific community. So far we only have information from case series.
- Detailed Description
The early skin to skin contact between mother and child in the first two hours postpartum is essential for bonding and breastfeeding. Coinciding with the widespread application of this procedure in hospitals have been described, in different countries, cases of children who have suffered episodes of apparent life threatening events (ALTEs) or early sudden deaths during the same procedure. The cause of these events is unclarified, it is unknown whether the position of the mother during the first two hours of a child's life affects their stability.
The investigators's hypothesis is that the frequency of episodes of oxygen saturation less than 91% in the first 2 hours of life of the newborn is reduced by one third in children whose mothers are incorporated at 45° above the horizontal plane of the bed compared with children whose mothers are incorporated to 15º.
This is a multicenter, randomized and controlled study in 10 Spanish hospitals with blind evaluation. 5866 participants will be enrolled in this study (a total of 1275 children are required in each arm of the study).
Mother/child (defined as a dyad) will be randomized in two groups:
Group A: head-of-bed elevated 15°. Group B: head-of-bed elevated 45°.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1243
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description head-of-bed elevated 45° Head-of-bed elevated 45° Mother's head-of-bead elevated 45°. Intervention: Head-of-bed elevated 45°during 2 hours after delivery. head-of-bed elevated 15° Head-of-bed elevated 15° Mother's head-of-bead elevated 15°. Intervention: Head-of-bed elevated 15° during 2 hours after the delivery.
- Primary Outcome Measures
Name Time Method Presence of at least one episode desaturation ≤90% Two first hours after delivery The evaluation will be done with a pulse oximeter (non-invasive Radical-7 Signal Extraction PulseCO-Oximeter equipped with Masimo Rainbow SET technology). All the technology used in all hospitals is part of Masimo's SafeyNet system.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Hospital Universitario Severo Ochoa
🇪🇸Leganés, Madrid, Spain
Hospital Universitario de Cruces
🇪🇸Bilbao, Vizcaya, Spain
Hospital La Fe
🇪🇸Valencia, Spain
Hospital Universitario Quirón
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital de Vielha
🇪🇸Lleida, Spain