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Effects of Mother Position in Skin-to-skin Contact Newborn on Oxygen Saturation Levels.

Primary Purpose

Neonatal Disorder

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Head-of-bed elevated 15°
Head-of-bed elevated 45°
Sponsored by
Red Salud Materno Infantil y del Desarrollo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neonatal Disorder

Eligibility Criteria

259 Days - 293 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion criteria:

  1. Single fetus pregnancy
  2. Pregnancy controlled or partially controlled(1)
  3. Normal pregnancy or with gestational diabetes treated with diet, high blood pressure controlled with only a drug as maximum (without preeclampsia)
  4. Gestation to term (between 37 weeks to 41 weeks and 6 days of gestational age).
  5. Maternal temperature at onset of labor ≤38 degrees Celsius
  6. Presence of a companion during the 2 hours after delivery
  7. Desire of the mother to perform early skin-to-skin

Exclusion criteria pre-randomization:

  1. Consumption of tobacco, alcohol, drugs or any medication with sedative or relaxing(2) effect or any pathology during pregnancy.
  2. Prenatal diagnosis of chromosomal abnormalities or major malformations.
  3. Prenatal diagnosis of intrauterine growth restriction with any degree of alteration in the flow as well as the abnormal small-for-gestational-age fetuses (due to malformations, intrauterine infection ...).
  4. No companion during the first two hours postpartum

Notes:

  1. Partially controlled pregnancy: she has the 20 weeks ultrasound but lack the first and/or third trimester of pregnancy and/or analytical (serology, O'Sullivan test ...).
  2. Medicinal products with sedative or relaxing effect: opioids, anticonvulsants, antipsychotics, benzodiazepines, anxiolytics, hypnotics, antidepressants and sedative plants.

Post randomization exclusion criteria (at the end of delivery)

  1. Related to childbirth:

    • Caesarean section or instrumental delivery (forceps, vacuum)
    • Maternal fever >38 degrees Celsius
    • Mother hemodynamic instability (hypotension, tachycardia, altered level of consciousness, poor perfusion, striking pallor)
    • Cord prolapse
    • Signs of fetal distress with lower pH fetal scalp <7.25 or umbilical artery pH <7.20
    • Any other obstetrical complication
  2. Related mother:

    • Any type of illness
    • Sedatives or relaxants during or after birth(3)
  3. Related Newborn (RN)

    • Need for resuscitation measures
    • Major malformation diagnosed intrapartum
    • Apgar ≤7 at one minute, 5 or 10 minutes
    • Presence of clinic(4) before the 10 minutes of life
    • Birth weight <2300 g or>4500 g
  4. 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:

  1. Newborns with intrauterine diagnosis of ectasia pyelocaliceal grades I and/or II, choroid plexus cysts, aberrant right subclavian artery or single umbilical artery (minor malformations).
  2. Newborns whose time broken bag is ≥ to 18 hours provided that they do not present clinic(4).
  3. Newborn with risk of infection without symptoms at birth.
  4. Newborn with stained amniotic fluid, born crying, who does not require tracheal aspiration, or resuscitation and shows no clinical(4) signs during the first 10 minutes after birth.
  5. Small for normal fetal gestational age (genetic-family origin)

Sites / Locations

  • Hospital Universitario Severo Ochoa
  • Hospital Universitario de Cruces
  • Hospital de Vielha
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario La Paz
  • Hospital Universitario Quirón
  • Hospital La Fe

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

head-of-bed elevated 15°

head-of-bed elevated 45°

Arm Description

Mother's head-of-bead elevated 15°. Intervention: Head-of-bed elevated 15° during 2 hours after the delivery.

Mother's head-of-bead elevated 45°. Intervention: Head-of-bed elevated 45°during 2 hours after delivery.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 22, 2015
Last Updated
October 26, 2018
Sponsor
Red Salud Materno Infantil y del Desarrollo
Collaborators
Hospital Universitario 12 de Octubre
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1. Study Identification

Unique Protocol Identification Number
NCT02585492
Brief Title
Effects of Mother Position in Skin-to-skin Contact Newborn on Oxygen Saturation Levels.
Official Title
Episodes of Decreased Oxygen Saturation in Newborns in Skin-to-skin Contact: Role of Maternal Position After Delivery. A Randomized Clinical Study.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Red Salud Materno Infantil y del Desarrollo
Collaborators
Hospital Universitario 12 de Octubre

4. Oversight

Data Monitoring Committee
No

5. Study Description

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°.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Disorder

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1243 (Actual)

8. Arms, Groups, and Interventions

Arm Title
head-of-bed elevated 15°
Arm Type
Active Comparator
Arm Description
Mother's head-of-bead elevated 15°. Intervention: Head-of-bed elevated 15° during 2 hours after the delivery.
Arm Title
head-of-bed elevated 45°
Arm Type
Experimental
Arm Description
Mother's head-of-bead elevated 45°. Intervention: Head-of-bed elevated 45°during 2 hours after delivery.
Intervention Type
Other
Intervention Name(s)
Head-of-bed elevated 15°
Intervention Description
Head-of-bed elevated 15° during 2 hours after delivery.
Intervention Type
Other
Intervention Name(s)
Head-of-bed elevated 45°
Intervention Description
Head-of-bed elevated 45° during 2 hours after delivery.
Primary Outcome Measure Information:
Title
Presence of at least one episode desaturation ≤90%
Description
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.
Time Frame
Two first hours after delivery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
259 Days
Maximum Age & Unit of Time
293 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: Single fetus pregnancy Pregnancy controlled or partially controlled(1) Normal pregnancy or with gestational diabetes treated with diet, high blood pressure controlled with only a drug as maximum (without preeclampsia) Gestation to term (between 37 weeks to 41 weeks and 6 days of gestational age). Maternal temperature at onset of labor ≤38 degrees Celsius Presence of a companion during the 2 hours after delivery Desire of the mother to perform early skin-to-skin Exclusion criteria pre-randomization: Consumption of tobacco, alcohol, drugs or any medication with sedative or relaxing(2) effect or any pathology during pregnancy. Prenatal diagnosis of chromosomal abnormalities or major malformations. Prenatal diagnosis of intrauterine growth restriction with any degree of alteration in the flow as well as the abnormal small-for-gestational-age fetuses (due to malformations, intrauterine infection ...). No companion during the first two hours postpartum Notes: Partially controlled pregnancy: she has the 20 weeks ultrasound but lack the first and/or third trimester of pregnancy and/or analytical (serology, O'Sullivan test ...). Medicinal products with sedative or relaxing effect: opioids, anticonvulsants, antipsychotics, benzodiazepines, anxiolytics, hypnotics, antidepressants and sedative plants. Post randomization exclusion criteria (at the end of delivery) Related to childbirth: Caesarean section or instrumental delivery (forceps, vacuum) Maternal fever >38 degrees Celsius Mother hemodynamic instability (hypotension, tachycardia, altered level of consciousness, poor perfusion, striking pallor) Cord prolapse Signs of fetal distress with lower pH fetal scalp <7.25 or umbilical artery pH <7.20 Any other obstetrical complication Related mother: Any type of illness Sedatives or relaxants during or after birth(3) Related Newborn (RN) Need for resuscitation measures Major malformation diagnosed intrapartum Apgar ≤7 at one minute, 5 or 10 minutes Presence of clinic(4) before the 10 minutes of life Birth weight <2300 g or>4500 g 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: Newborns with intrauterine diagnosis of ectasia pyelocaliceal grades I and/or II, choroid plexus cysts, aberrant right subclavian artery or single umbilical artery (minor malformations). Newborns whose time broken bag is ≥ to 18 hours provided that they do not present clinic(4). Newborn with risk of infection without symptoms at birth. Newborn with stained amniotic fluid, born crying, who does not require tracheal aspiration, or resuscitation and shows no clinical(4) signs during the first 10 minutes after birth. Small for normal fetal gestational age (genetic-family origin)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadia R. García Lara, Dra
Organizational Affiliation
Hospital Universitario 12 de Octubre
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Universitario Severo Ochoa
City
Leganés
State/Province
Madrid
ZIP/Postal Code
28911
Country
Spain
Facility Name
Hospital Universitario de Cruces
City
Bilbao
State/Province
Vizcaya
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital de Vielha
City
Lleida
ZIP/Postal Code
25530
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Quirón
City
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
Hospital La Fe
City
Valencia
ZIP/Postal Code
46022
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30894206
Citation
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.
Results Reference
derived

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Effects of Mother Position in Skin-to-skin Contact Newborn on Oxygen Saturation Levels.

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