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| Name | Class |
|---|---|
| Hospital Universitario 12 de Octubre | OTHER |
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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.
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°.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| head-of-bed elevated 15° | Active Comparator | Mother's head-of-bead elevated 15°. Intervention: Head-of-bed elevated 15° during 2 hours after the delivery. |
|
| head-of-bed elevated 45° | Experimental | Mother's head-of-bead elevated 45°. Intervention: Head-of-bed elevated 45°during 2 hours after delivery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Head-of-bed elevated 15° | Other | Head-of-bed elevated 15° during 2 hours after delivery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of at least one episode desaturation ≤90% | 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. | Two first hours after delivery |
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Inclusion criteria:
Exclusion criteria pre-randomization:
Notes:
Post randomization exclusion criteria (at the end of delivery)
Related to childbirth:
Related mother:
Related Newborn (RN)
Interruption of skin contact because the mother present a problem
Notes:
(3) Sedatives or relaxants during or after birth: Pethidine (Dolantina®), scopolamine (Buscapina®), haloperidol, benzodiazepines and opiates.
(4) Clinic: general discomfort, fever, hypothermia, pallor, mottled skin (cutis marmorata), cyanosis, petechiae, purpura, lethargy, weakness, poor responsiveness, seizures, tremors, poor perfusion, maintained tachycardia, bradycardia, hypotension, apnea, tachypnea, respiratory distress (grunting, nasal flaring, intercostal or subcostal or substernal retractions, thoracoabdominal dissociation), vomiting, abdominal distesion, etc.
Clarifications:
It can include:
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| Name | Affiliation | Role |
|---|---|---|
| Nadia R. García Lara, Dra | Hospital Universitario 12 de Octubre | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Severo Ochoa | Leganés | Madrid | 28911 | Spain | ||
| Hospital Universitario de Cruces |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30894206 | Derived | Rodriguez Lopez J, Garcia Lara NR, Lopez Maestro M, De la Cruz Bertolo J, Martinez Avila JC, Vento M, Parra Llorca A, Izquierdo Macian I, Pellicer A, Marin Huarte N, Asla Elorriaga I, Roman Echevarria L, Copons Fernandez C, Martin Ancel A, Cabanas F, Garcia Algar O, Pallas Alonso CR. What is the impact of mother's bed incline on episodes of decreased oxygen saturation in healthy newborns in skin-to-skin contact after delivery: Study protocol for a randomized controlled trial. Trials. 2019 Mar 20;20(1):179. doi: 10.1186/s13063-019-3256-0. |
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| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| Head-of-bed elevated 45° | Other | Head-of-bed elevated 45° during 2 hours after delivery. |
|
| Bilbao |
| Vizcaya |
| 48903 |
| Spain |
| Hospital de Vielha | Lleida | 25530 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Universitario Quirón | Madrid | 28223 | Spain |
| Hospital La Fe | Valencia | 46022 | Spain |