Effects of Mother Position in Skin-to-skin Contact Newborn on Oxygen Saturation Levels.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02585492|
Recruitment Status : Completed
First Posted : October 23, 2015
Last Update Posted : October 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Neonatal Disorder||Other: Head-of-bed elevated 15° Other: Head-of-bed elevated 45°||Not Applicable|
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°.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1243 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Episodes of Decreased Oxygen Saturation in Newborns in Skin-to-skin Contact: Role of Maternal Position After Delivery. A Randomized Clinical Study.|
|Actual Study Start Date :||November 2015|
|Actual Primary Completion Date :||April 2018|
|Actual Study Completion Date :||April 2018|
Active Comparator: head-of-bed elevated 15°
Mother's head-of-bead elevated 15°. Intervention: Head-of-bed elevated 15° during 2 hours after the delivery.
Other: Head-of-bed elevated 15°
Head-of-bed elevated 15° during 2 hours after delivery.
Experimental: head-of-bed elevated 45°
Mother's head-of-bead elevated 45°. Intervention: Head-of-bed elevated 45°during 2 hours after delivery.
Other: Head-of-bed elevated 45°
Head-of-bed elevated 45° during 2 hours after delivery.
- Presence of at least one episode desaturation ≤90% [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02585492
|Hospital Universitario Severo Ochoa|
|Leganés, Madrid, Spain, 28911|
|Hospital Universitario de Cruces|
|Bilbao, Vizcaya, Spain, 48903|
|Hospital de Vielha|
|Lleida, Spain, 25530|
|Hospital Universitario 12 de Octubre|
|Madrid, Spain, 28041|
|Hospital Universitario La Paz|
|Madrid, Spain, 28046|
|Hospital Universitario Quirón|
|Madrid, Spain, 28223|
|Hospital La Fe|
|Valencia, Spain, 46022|
|Study Chair:||Nadia R. García Lara, Dra||Hospital Universitario 12 de Octubre|