PregnancyNCT02143193
Skin-to Skin Contact on Newborn Temperature
A study testing Skin-to-Skin Contact in people with Pregnancy and Skin to Skin Contact, run by Rachel Baker at 1 site in United States.
Trial summary
This study will compare standard methods of stabilizing a newborn's temperature after birth with mother-infant skin-to-skin contact for stabilizing newborn temperature. The study will look at the effects of each warming method on the timing of newborns' initial bath and the effects on newborn initiation and percent… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Skin to Skin Contact
- What is being tested?
- Skin-to-Skin Contact
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 325 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to May 2014
- 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Woman in labor presenting with
- An uncomplicated pregnancy
- Full-term gestation: 38 0/7 weeks
- Single gestation
- Vertex presentation
- Plans to deliver without general anesthesia
- Likelihood of a vaginal delivery
Who cannot join
- A complication of pregnancy at the time of admission
- An inability to speak or understand English language
- Preterm gestation: 37 6/7 weeks
- A multiple gestation
- Non-vertex presentation
- Plan for delivery with general anesthesia
- Planned Cesarean delivery
Trial locations and contacts
1 site in 1 country.
United States1 site
Good Samaritan TriHealth Hospital
Cincinnati, Ohio, 45220
About this study
Official title: The Effects of Skin-to-Skin Contact on Newborn Temperature, Initial Bath and Early Breastfeefing
This study will compare standard methods of stabilizing a newborn's temperature after birth with mother-infant skin-to-skin contact for stabilizing newborn temperature. The study will look at the effects of each warming method on the timing of newborns' initial bath and the effects on newborn initiation and percent weight loss by discharge.
The study will use a randomized controlled trial (RCT) design to test a clinical intervention at TriHealth Good Samaritan Hospital. Study participants will be randomized to the intervention group (IG), which will implement mother-baby Skin-to-Skin (STS) immediately after vaginal birth, or to the control group (CG), which will receive standard care for newborn and mother immediately after vaginal birth.
Read more
This study will test the hypothesis that mother-baby STS contact implemented immediately after delivery for a minimum of the newborn's first 60 minutes and with a resumption of STS (if a 15-minute break in STS occurs at some point after the first hour) until the newborn's temperature stabilizes after the initial bath will result in:
- Improved newborn temperature stability and thermoregulation for newborns whether breast or formula-fed.
- Initiation of effective breastfeeding behavior within 90 minutes of birth and the addition of at least one more breastfeeding within four hours of birth for breastfed newborns.
- Avoidance of newborn weight loss of 10% or greater.
- Conditions
- Pregnancy, Skin to Skin Contact
- Being tested
- Skin-to-Skin Contact
- Keywords
- Breastfeeding, Newborn, Formula, Temperature, Initial Bath
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin-to-Skin ContactBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Skin to Skin Contact | Experimental | implement mother-baby Skin-to-Skin contact immediately after vaginal birth Receives: Behavioral: Skin-to-Skin Contact |
| Standard of Care | No intervention | standard care for newborn and mother immediately after vaginal birth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to temperature stabilization until initial bath
Measured: one minute to 60 minutes after birth
Secondary outcomes (1)
Time required for temperature re-stabilization after initial bath
Measured: on minute after initial bath until baby reaches desired temperature
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startAug 2011
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rachel Baker
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rachel Baker, TriHealth Inc.
- Investigators
- Karen Gromada, MSN, RN, Principal investigator, TriHealth Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02143193
- Sponsor's protocol ID
- 11082-11-058
- Status last verified
- Feb 2017
- First submitted
- 16 May 2014
- Last updated
- 23 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Skin-to-Skin Contact on Newborn Temperature, Initial Bath and Early Breastfeefing
- ClinicalTrials.gov ID
- NCT02143193
- Acronym / sponsor ID
- 11082-11-058
- Conditions
- Pregnancy, Skin to Skin Contact
- Keywords
- Breastfeeding, Newborn, Formula, Temperature, Initial Bath
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- Rachel BakerUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 20 May 2014 (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.
This study will compare standard methods of stabilizing a newborn's temperature after birth with mother-infant skin-to-skin contact for stabilizing newborn temperature. The study will look at the effects of each warming method on the timing of newborns' initial bath and the effects on newborn initiation and percent weight loss by discharge.
The study will use a randomized controlled trial (RCT) design to test a clinical intervention at TriHealth Good Samaritan Hospital. Study participants will be randomized to the intervention group (IG), which will implement mother-baby Skin-to-Skin (STS) immediately after vaginal birth, or to the control group (CG), which will receive standard care for newborn and mother immediately after vaginal birth.
This study will test the hypothesis that mother-baby STS contact implemented immediately after delivery for a minimum of the newborn's first 60 minutes and with a resumption of STS (if a 15-minute break in STS occurs at some point after the first hour) until the newborn's temperature stabilizes after the initial bath will result in:
- Improved newborn temperature stability and thermoregulation for newborns whether breast or formula-fed.
- Initiation of effective breastfeeding behavior within 90 minutes of birth and the addition of at least one more breastfeeding within four hours of birth for breastfed newborns.
- Avoidance of newborn weight loss of 10% or greater.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Skin to Skin Contact | Experimental | Behavioral: Skin-to-Skin Contactimplement mother-baby Skin-to-Skin contact immediately after vaginal birth |
| Standard of Care | No intervention | –standard care for newborn and mother immediately after vaginal birth |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Woman in labor presenting with
- An uncomplicated pregnancy
- Full-term gestation: 38 0/7 weeks
- Single gestation
- Vertex presentation
Key exclusion criteria (7 listed)
- A complication of pregnancy at the time of admission
- An inability to speak or understand English language
- Preterm gestation: 37 6/7 weeks
- A multiple gestation
- Non-vertex presentation
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 |
|---|---|---|
| Skin-to-Skin Contact | Behavioural | Skin to Skin Contact |
Primary outcome
Time to temperature stabilization until initial bath
Time frame: one minute to 60 minutes after birth
1 secondary outcome
Time required for temperature re-stabilization after initial bath
Time frame: on minute after initial bath until baby reaches desired temperature
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 23 Aug 2018.
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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.
Karen Gromada, MSN, RN principal investigator
TriHealth Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin-to-Skin Contact in people with Pregnancy and Skin to Skin Contact, run by Rachel Baker at 1 site in United States.
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 7 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 23 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Time to temperature stabilization until initial bath (time frame: one minute to 60 minutes after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Aug 2018.