Neonatal DisorderNCT02585492
Effects of Mother Position in Skin-to-skin Contact Newborn on Oxygen Saturation Levels.
A study testing Head-of-bed elevated 15° and Head-of-bed elevated 45° in people with Neonatal Disorder, run by Red Salud Materno Infantil y del Desarrollo at 7 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 259 to 293 daysHealthy volunteers can take part
- Conditions the study is for
- Neonatal Disorder
- What is being tested?
- Head-of-bed elevated 15° and Head-of-bed elevated 45°
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,243 participants
- Where
- 7 sitesSpain
- Study dates
- Nov 2015to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 259 to 293 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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 ...).
Show all 35Show fewer
- 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:
- Sedatives or relaxants during or after birth: Pethidine (Dolantina®), scopolamine (Buscapina®), haloperidol, benzodiazepines and opiates.
- 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)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Spain7 sites
Hospital Universitario de Cruces
Bilbao, Vizcaya, 48903
Hospital Universitario Severo Ochoa
Leganés, Madrid, 28911
Hospital de Vielha
Lleida, 25530
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario Quirón
Madrid, 28223
Hospital La Fe
Valencia, 46022
About this study
Official title: Episodes of Decreased Oxygen Saturation in Newborns in Skin-to-skin Contact: Role of Maternal Position After Delivery. A Randomized Clinical Study.
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.
Read the 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°.
- Conditions
- Neonatal Disorder
- Being tested
- Head-of-bed elevated 15°, Head-of-bed elevated 45°
- Medical subject headings
- Infant, Newborn, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head-of-bed elevated 15°Other
Head-of-bed elevated 15° during 2 hours after delivery.
Head-of-bed elevated 45°Other
Head-of-bed elevated 45° during 2 hours after delivery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Head-of-bed elevated 15° |
| head-of-bed elevated 45° | Experimental | Mother's head-of-bead elevated 45°. Intervention: Head-of-bed elevated 45°during 2 hours after delivery. Receives: Other: Head-of-bed elevated 45° |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two first hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neonatal DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,243 participants (actual)
Sponsor and investigators
- Lead sponsor
- Red Salud Materno Infantil y del Desarrollo
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario 12 de Octubre
- Responsible party
- Sponsor
- Investigators
- Nadia R. García Lara, Dra, Study chair, Hospital Universitario 12 de Octubre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02585492
- Sponsor's protocol ID
- Neonatologia-2014-02
- Status last verified
- Oct 2018
- First submitted
- 22 Oct 2015
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 30894206
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Episodes of Decreased Oxygen Saturation in Newborns in Skin-to-skin Contact: Role of Maternal Position After Delivery. A Randomized Clinical Study.
- ClinicalTrials.gov ID
- NCT02585492
- Acronym / sponsor ID
- Neonatologia-2014-02
- Conditions
- Neonatal Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,243 participants (actual)
- Lead sponsor
- Red Salud Materno Infantil y del DesarrolloUniversity, hospital or other
- Collaborators
- Hospital Universitario 12 de Octubre
- Study start
- Nov 2015 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 23 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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°.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| head-of-bed elevated 15° | Active comparator | Other: Head-of-bed elevated 15°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 | Other: Head-of-bed elevated 45°Mother's head-of-bead elevated 45°. Intervention: Head-of-bed elevated 45°during 2 hours after delivery. |
Who may qualify
- Ages
- 259 to 293 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (35 listed)
- 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
- 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 ...).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Head-of-bed elevated 15°Head-of-bed elevated 15° during 2 hours after delivery. | Other | head-of-bed elevated 15° |
| Head-of-bed elevated 45°Head-of-bed elevated 45° during 2 hours after delivery. | Other | head-of-bed elevated 45° |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
- Derived from this study: PubMed 30894206Rodriguez 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.
- Individual participant dataSharing planned: No
Related trials for Neonatal Disorder
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadia R. García Lara, Dra study chair
Hospital Universitario 12 de Octubre
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Head-of-bed elevated 15° and Head-of-bed elevated 45° in people with Neonatal Disorder, run by Red Salud Materno Infantil y del Desarrollo at 7 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of at least one episode desaturation ≤90% (time frame: Two first hours after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02585492, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2018.