Premature Baby 33 to 36 WeeksPRCTS2SNCT04368767
A Pilot Randomized Controlled Trial of the Effects of Daily Skin-to-skin Contact (PRCTS2S)
A study testing Skin-to-skin in people with Premature Baby 33 to 36 Weeks and Mother-Infant Interaction, run by University of California, San Francisco at 1 site in United States.
Trial summary
Late preterm infants are at risk of experiencing inadequate glycogen stores with immature glucose metabolism and increased adenosine triphosphate (ATP) degradation, which indicates cellular increased and stress. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Premature Baby 33 to 36 Weeks, Mother-Infant Interaction, Oxidative Stress
- What is being tested?
- Skin-to-skin
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2020to 30 Sep 2020
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Infants between 34 weeks and 0/7 days through 35 weeks and 6/7 days gestational age
- Medically stable as determined by a Neonatal Acute Physiology- Perinatal Extension SNAPPE -II (SNAPPE-II) score of less than 9
- Mothers able to read and write English
- Mothers have no medical contraindications to holding their infant in SSC for up to 2 hours
Who cannot join
- Surgery in the first week of life
- Intraventricular hemorrhage (IVH) of grade 3 or 4
- Opioids, benzodiazepines, muscle relaxants, phenobarbital, and/or dilantin
- Plasma creatinine of >1 mg/dl
- Severe cyanotic heart disease or severe respiratory distress
- Abdominal wall or intestinal anomaly or injury (NEC)
- Facial anomaly or other known chromosomal anomaly
- Life-threatening congenital anomaly or are so critically ill that they are unlikely to survive or are receiving palliative care
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Benioff Children's Hospital San Francisco
San Francisco, California, 94158
About this study
Official title: A Pilot Randomized Controlled Trial of the Effects of Daily Skin-to-skin Contact Compared to Standard Care on the Stress Responses of Late Preterm Infants in the First Week of Life
Late preterm infants are at risk of experiencing inadequate glycogen stores with immature glucose metabolism and increased adenosine triphosphate (ATP) degradation, which indicates cellular increased and stress. Processes mediating infant acute/chronic stress symptoms and their biochemical effects have not been adequately investigated. Skin-to-skin contact (SSC), also known as Kangaroo Mother Care (KMC), is as an intervention that activates mechanisms of energy preservation that decrease stress in preterm infants. SSC has been shown in numerous clinical trials to reduce mortality and morbidity by stabilization of breathing, thermal regulation, oxygen saturation, and heart rate. SSC also reduces behavioral distress during painful and stressful procedures and improves breast-feeding parent bonding. However, little is known about how SSC affects biomarkers of stress and energy expenditure in late preterm infants in the first week of life.
The aim of this pilot randomized controlled trial is to evaluate changes in biomarkers of stress, stress modulation and energy expenditure in late preterm infants who receive two hours of continuous SSC care or two hours of lying undisturbed in an incubator administered daily for 3 consecutive days in the first week of life, and to provide preliminary data for future research comparing the effects of usual incubator care with prolonged SSC on stress biomarkers in preterm infants.
- Being tested
- Skin-to-skin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin-to-skinBehavioural
Skin-to-skin contact will be performed for two hours daily for three consecutive days in the first week of life, usually in the afternoon. This time interval will allow all pre-intervention sample collection to begin 1 hour after the infant's feeding schedule in the afternoon. After pre-intervention measures of axillary temperature, heart rate, respiratory rate, and oxygen saturation by pulse oximetry (SPO2) are obtained; cotton balls placed in the diaper for urine collection will be removed and stored in an appropriate container. Salivary oxytocin and cortisol will be collected per protocol below. Mothers will be requested to sit in reclining chairs with a front opened blouse or hospital gown. Infants will be removed from the incubator and placed naked except for a diaper and hat directly onto the skin between the mother's breasts and covered with a blanket. All infants will be monitored. After the two hours of SSC is completed, the infant will be returned to the incubator.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care: Incubator | No intervention | The infant will remain in the incubator and stress biomarkers will be collected per protocol |
| Intervention: Skin-to-skin | Experimental | Skin-to-skin contact will be performed for two hours daily for three consecutive days in the first week of life, 30 minutes after feeding. SSC will usually occur in the afternoon between 11:30-12:30 pm or 14:30-15:30pm. This time interval will allow all pre-intervention sample collection to begin 1 hour after the infant's feeding schedule in the afternoon. The room will be monitored to maintain a temperature of 72-77 degrees Fahrenheit during SSC. Stress biomarkers will be collected per protocol. Receives: Behavioral: Skin-to-skin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress biomarkers
Compare group differences in measures of stress (i.e., salivary cortisol, urinary biomarkers of Hx, Xa, UA, and allantoin, and stress buffering (i.e., salivary oxytocin) between the intervention and usual care groups.
Measured: Day 3
Stress biomarkers
Compare group differences in measures of stress (i.e., salivary cortisol, urinary biomarkers of Hx, Xa, UA, and allantoin, and stress buffering (i.e., salivary oxytocin) between the intervention and usual care groups.
Measured: Day 2
Stress biomarkers
Compare group differences in measures of stress (i.e., salivary cortisol, urinary biomarkers of Hx, Xa, UA, and allantoin, and stress buffering (i.e., salivary oxytocin) between the intervention and usual care groups.
Measured: Day 1
Secondary outcomes (8)
Mother's Satisfaction with SSC
Mother's Satisfaction with SSC Questionnaire
Measured: Day 3
Number of discomforting and stressful events for mother
Total count of discomfort and stressful events
Measured: Day 3
Number of discomforting and stressful events for mother
Total count of discomfort and stressful events
Measured: Day 2
Number of discomforting and stressful events for mother
Total count of discomfort and stressful events
Measured: Day 1
Number of discomforting and stressful events for infant
Total count of discomforting and stressful events
Measured: Day 3
Number of discomforting and stressful events for infant
Total count of discomforting and stressful events
Measured: Day 2
Number of discomforting and stressful events for infant
Total count of discomforting and stressful events
Measured: Day 1
Change in stress biomarkers
salivary cortisol, urinary biomarkers of Hx, Xa, Uric Acid (UA), and allantoin and stress buffering (i.e., salivary oxytocin
Measured: pre and post the intervention on days 1, 2, and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start3 Aug 2020
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Premature Baby 33 to 36 WeeksStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We will use a randomized controlled trial design to examine feasibility of the prolonged SSC intervention in the first week of life for late preterm infants and to provide preliminary data for future research to compare the effects of usual incubator care with prolonged SSC on biomarkers of stress in late preterm infants in the first week of life.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linda Franck, RN, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04368767
- Sponsor's protocol ID
- 19-29543
- Acronym
- PRCTS2S
- Status last verified
- Nov 2020
- First submitted
- 26 Nov 2019
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Isayama T, Lewis-Mikhael AM, O'Reilly D, Beyene J, McDonald SD. Health Services Use by Late Preterm and Term Infants From Infancy to Adulthood: A Meta-analysis. Pediatrics. 2017 Jul;140(1):e20170266. doi: 10.1542/peds.2017-0266.
PubMed 28759410Blass E. Energy conservation in infants. Behav Processes. 2015 Aug;117:35-41. doi: 10.1016/j.beproc.2015.01.011. Epub 2015 Jan 30.
PubMed 25643950Tan JBC, Boskovic DS, Angeles DM. The Energy Costs of Prematurity and the Neonatal Intensive Care Unit (NICU) Experience. Antioxidants (Basel). 2018 Mar 2;7(3):37. doi: 10.3390/antiox7030037.
PubMed 29498645Chi Luong K, Long Nguyen T, Huynh Thi DH, Carrara HP, Bergman NJ. Newly born low birthweight infants stabilise better in skin-to-skin contact than when separated from their mothers: a randomised controlled trial. Acta Paediatr. 2016 Apr;105(4):381-90. doi: 10.1111/apa.13164. Epub 2015 Oct 15.
PubMed 26303808Morelius E, He HG, Shorey S. Salivary Cortisol Reactivity in Preterm Infants in Neonatal Intensive Care: An Integrative Review. Int J Environ Res Public Health. 2016 Mar 18;13(3):337. doi: 10.3390/ijerph13030337.
PubMed 26999185Kim KM, Henderson GN, Ouyang X, Frye RF, Sautin YY, Feig DI, Johnson RJ. A sensitive and specific liquid chromatography-tandem mass spectrometry method for the determination of intracellular and extracellular uric acid. J Chromatogr B Analyt Technol Biomed Life Sci. 2009 Jul 15;877(22):2032-8. doi: 10.1016/j.jchromb.2009.05.037. Epub 2009 May 27.
PubMed 19520625Tolun AA, Zhang H, Il'yasova D, Sztaray J, Young SP, Millington DS. Allantoin in human urine quantified by ultra-performance liquid chromatography-tandem mass spectrometry. Anal Biochem. 2010 Jul 15;402(2):191-3. doi: 10.1016/j.ab.2010.03.033. Epub 2010 Mar 31.
PubMed 20361921Cong X, Ludington-Hoe SM, Hussain N, Cusson RM, Walsh S, Vazquez V, Briere CE, Vittner D. Parental oxytocin responses during skin-to-skin contact in pre-term infants. Early Hum Dev. 2015 Jul;91(7):401-6. doi: 10.1016/j.earlhumdev.2015.04.012. Epub 2015 May 16.
PubMed 25988992Plank MS, Calderon TC, Asmerom Y, Boskovic DS, Angeles DM. Biochemical measurement of neonatal hypoxia. J Vis Exp. 2011 Aug 24;(54):2948. doi: 10.3791/2948.
PubMed 21897351
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial of the Effects of Daily Skin-to-skin Contact Compared to Standard Care on the Stress Responses of Late Preterm Infants in the First Week of Life
- ClinicalTrials.gov ID
- NCT04368767
- Acronym / sponsor ID
- PRCTS2S / 19-29543
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 30 Apr 2020 (actual)
- 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.
Late preterm infants are at risk of experiencing inadequate glycogen stores with immature glucose metabolism and increased adenosine triphosphate (ATP) degradation, which indicates cellular increased and stress. Processes mediating infant acute/chronic stress symptoms and their biochemical effects have not been adequately investigated. Skin-to-skin contact (SSC), also known as Kangaroo Mother Care (KMC), is as an intervention that activates mechanisms of energy preservation that decrease stress in preterm infants. SSC has been shown in numerous clinical trials to reduce mortality and morbidity by stabilization of breathing, thermal regulation, oxygen saturation, and heart rate. SSC also reduces behavioral distress during painful and stressful procedures and improves breast-feeding parent bonding. However, little is known about how SSC affects biomarkers of stress and energy expenditure in late preterm infants in the first week of life.
The aim of this pilot randomized controlled trial is to evaluate changes in biomarkers of stress, stress modulation and energy expenditure in late preterm infants who receive two hours of continuous SSC care or two hours of lying undisturbed in an incubator administered daily for 3 consecutive days in the first week of life, and to provide preliminary data for future research comparing the effects of usual incubator care with prolonged SSC on stress biomarkers in preterm infants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We will use a randomized controlled trial design to examine feasibility of the prolonged SSC intervention in the first week of life for late preterm infants and to provide preliminary data for future research to compare the effects of usual incubator care with prolonged SSC on biomarkers of stress in late preterm infants in the first week of life.
| Arm | Type | Receives |
|---|---|---|
| Usual Care: Incubator | No intervention | –The infant will remain in the incubator and stress biomarkers will be collected per protocol |
| Intervention: Skin-to-skin | Experimental | Behavioral: Skin-to-skinSkin-to-skin contact will be performed for two hours daily for three consecutive days in the first week of life, 30 minutes after feeding. SSC will usually occur in the afternoon between 11:30-12:30 pm or 14:30-15:30pm. This time interval will allow all pre-intervention sample collection to begin 1 hour after the infant's feeding schedule in the afternoon. The room will be monitored to maintain a temperature of 72-77 degrees Fahrenheit during SSC. Stress biomarkers will be collected per protocol. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Infants between 34 weeks and 0/7 days through 35 weeks and 6/7 days gestational age
- Medically stable as determined by a Neonatal Acute Physiology- Perinatal Extension SNAPPE -II (SNAPPE-II) score of less than 9
- Mothers able to read and write English
- Mothers have no medical contraindications to holding their infant in SSC for up to 2 hours
Key exclusion criteria (8 listed)
- Surgery in the first week of life
- Intraventricular hemorrhage (IVH) of grade 3 or 4
- Opioids, benzodiazepines, muscle relaxants, phenobarbital, and/or dilantin
- Plasma creatinine of >1 mg/dl
- Severe cyanotic heart disease or severe respiratory distress
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-skinSkin-to-skin contact will be performed for two hours daily for three consecutive days in the first week of life, usually in the afternoon. This time interval will allow all pre-intervention sample collection to begin 1 hour after the infant's feeding schedule in the afternoon. After pre-intervention measures of axillary temperature, heart rate, respiratory rate, and oxygen saturation by pulse oximetry (SPO2) are obtained; cotton balls placed in the diaper for urine collection will be removed and stored in an appropriate container. Salivary oxytocin and cortisol will be collected per protocol below. Mothers will be requested to sit in reclining chairs with a front opened blouse or hospital gown. Infants will be removed from the incubator and placed naked except for a diaper and hat directly onto the skin between the mother's breasts and covered with a blanket. All infants will be monitored. After the two hours of SSC is completed, the infant will be returned to the incubator. | Behavioural | Intervention: Skin-to-skin |
Primary outcome
Stress biomarkers
Time frame: Day 3
Compare group differences in measures of stress (i.e., salivary cortisol, urinary biomarkers of Hx, Xa, UA, and allantoin, and stress buffering (i.e., salivary oxytocin) between the intervention and usual care groups.
Stress biomarkers
Time frame: Day 2
Compare group differences in measures of stress (i.e., salivary cortisol, urinary biomarkers of Hx, Xa, UA, and allantoin, and stress buffering (i.e., salivary oxytocin) between the intervention and usual care groups.
Stress biomarkers
Time frame: Day 1
Compare group differences in measures of stress (i.e., salivary cortisol, urinary biomarkers of Hx, Xa, UA, and allantoin, and stress buffering (i.e., salivary oxytocin) between the intervention and usual care groups.
8 secondary outcomes
Mother's Satisfaction with SSC
Time frame: Day 3
Number of discomforting and stressful events for mother
Time frame: Day 3
Number of discomforting and stressful events for mother
Time frame: Day 2
Number of discomforting and stressful events for mother
Time frame: Day 1
Number of discomforting and stressful events for infant
Time frame: Day 3
Number of discomforting and stressful events for infant
Time frame: Day 2
Number of discomforting and stressful events for infant
Time frame: Day 1
Change in stress biomarkers
Time frame: pre and post the intervention on days 1, 2, and 3
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 12 Nov 2020.
- Results publication: PubMed 28759410Isayama T, Lewis-Mikhael AM, O'Reilly D, Beyene J, McDonald SD. Health Services Use by Late Preterm and Term Infants From Infancy to Adulthood: A Meta-analysis. Pediatrics. 2017 Jul;140(1):e20170266. doi: 10.1542/peds.2017-0266.
- Results publication: PubMed 25643950Blass E. Energy conservation in infants. Behav Processes. 2015 Aug;117:35-41. doi: 10.1016/j.beproc.2015.01.011. Epub 2015 Jan 30.
- Results publication: PubMed 29498645Tan JBC, Boskovic DS, Angeles DM. The Energy Costs of Prematurity and the Neonatal Intensive Care Unit (NICU) Experience. Antioxidants (Basel). 2018 Mar 2;7(3):37. doi: 10.3390/antiox7030037.
- Results publication: PubMed 26303808Chi Luong K, Long Nguyen T, Huynh Thi DH, Carrara HP, Bergman NJ. Newly born low birthweight infants stabilise better in skin-to-skin contact than when separated from their mothers: a randomised controlled trial. Acta Paediatr. 2016 Apr;105(4):381-90. doi: 10.1111/apa.13164. Epub 2015 Oct 15.
- Results publication: PubMed 26999185Morelius E, He HG, Shorey S. Salivary Cortisol Reactivity in Preterm Infants in Neonatal Intensive Care: An Integrative Review. Int J Environ Res Public Health. 2016 Mar 18;13(3):337. doi: 10.3390/ijerph13030337.
- Results publication: PubMed 19520625Kim KM, Henderson GN, Ouyang X, Frye RF, Sautin YY, Feig DI, Johnson RJ. A sensitive and specific liquid chromatography-tandem mass spectrometry method for the determination of intracellular and extracellular uric acid. J Chromatogr B Analyt Technol Biomed Life Sci. 2009 Jul 15;877(22):2032-8. doi: 10.1016/j.jchromb.2009.05.037. Epub 2009 May 27.
- Results publication: PubMed 20361921Tolun AA, Zhang H, Il'yasova D, Sztaray J, Young SP, Millington DS. Allantoin in human urine quantified by ultra-performance liquid chromatography-tandem mass spectrometry. Anal Biochem. 2010 Jul 15;402(2):191-3. doi: 10.1016/j.ab.2010.03.033. Epub 2010 Mar 31.
- Results publication: PubMed 25988992Cong X, Ludington-Hoe SM, Hussain N, Cusson RM, Walsh S, Vazquez V, Briere CE, Vittner D. Parental oxytocin responses during skin-to-skin contact in pre-term infants. Early Hum Dev. 2015 Jul;91(7):401-6. doi: 10.1016/j.earlhumdev.2015.04.012. Epub 2015 May 16.
- Results publication: PubMed 21897351Plank MS, Calderon TC, Asmerom Y, Boskovic DS, Angeles DM. Biochemical measurement of neonatal hypoxia. J Vis Exp. 2011 Aug 24;(54):2948. doi: 10.3791/2948.
- Individual participant dataSharing planned: No
Related trials for Premature Baby 33 to 36 Weeks
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Premature - Weight 1000g-2499g or Gestation of 28-37weeks, Premature Baby 26 to 32 Weeks
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.
Linda Franck, RN, PhD principal investigator
University of California, San Francisco
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 in people with Premature Baby 33 to 36 Weeks and Mother-Infant Interaction, run by University of California, San Francisco 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 4 inclusion and 8 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 12 Nov 2020. 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?
Stress biomarkers (time frame: Day 3). The study lists 3 primary outcomes in all. 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 NCT04368767, which also lists 9 linked publications.
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 12 Nov 2020.