Preterm InfantNCT05503238
The Effects of Mother-infant Skin-to-skin Contact on Stress Response of Preterm Infants
A study testing Skin-to-skin contact and Routine care in people with Preterm Infant, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
This study will evaluate the effect of maternal-infant skin-to-skin contact (SSC) versus routine care on general stress in preterm infants in the neonatal intensive care unit (NICU). Read more about this study
- Who is it for?
- Ages 0 to 24 hours
- Conditions the study is for
- Preterm Infant
- What is being tested?
- Skin-to-skin contact and Routine care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 30 Jun 2026
- 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 0 to 24 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 31 weeks≤gestational age<37 weeks;
- Birth weight ≥ 1500g;
- Admission age < 24h;
- No congenital malformations;
- Vital signs are stable and does not use ventilator and other auxiliary life support systems.
Who cannot join
- Severe periventricular / intraventricular hemorrhage (grade III);
- Receiving sedation or vasopressor or analgesics opiodis and corticosteroids;
- Mother unable to communicate and communicate normally; Mother has a history of depression.
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
About this study
Official title: The Effects of Mother-infant Skin-to-skin Contact on Cumulative Stress of Preterm Infants in the Neonatal Intensive Care Unit : A Randomized Controlled Trial
This study will evaluate the effect of maternal-infant skin-to-skin contact (SSC) versus routine care on general stress in preterm infants in the neonatal intensive care unit (NICU).
Read the detailed description
Primary outcome of this trial to investigate the effects daily skin-to-skin contact on cumulative stress through measures salivary cortisol. The intervention group will receive mother-infant skin-to-skin contact at least 1 continuous hour everyday from infant 3 days of life until discharge. The control group will receive routine neonatal care during hospitalization except skin-to-skin contact. The concentration of salivary cortisol and other infant and parental outcomes will be measured in both groups.
- Conditions
- Preterm Infant
- Being tested
- Skin-to-skin contact, Routine care
- Keywords
- Stress response, Skin-to-skin contact, Cortisol
- Medical subject headings
- Premature Birth, Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin-to-skin contactBehavioural
Preterm infants will receive maternal-infant skin-to-skin contact at least 1 continuous hour everyday from infant 3 days of life until discharge, and other nursing care will be same as the routine group. During skin-to-skin contact, place naked baby only with diaper on the mother's bare chest in an upright position and tilt the baby's head to one side in a slightly extended position to keeps the airway open, cover the infant with a blanket to keep them warm. A neonatal nurse will be stay with mother and infant to observe and support.
Routine careOther
Preterm infants will receive standard nursing care provided by neonatal nurses in accordance with hospital principles during hospitalization.
| Study group | Role | What they receive |
|---|---|---|
| Skin-to-skin contact group | Experimental | Provide maternal-infant skin-to-skin contact for preterm infants in the neonatal intensive care unit. Receives: Behavioral: Skin-to-skin contact; Other: Routine care |
| Routine care group | Other | Perform routine nursing care for preterm infants in the neonatal intensive care unit. Receives: Other: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes on the concentration of cortisol of preterm infants
At 3 days of life (baseline) and 7 days of life, the saliva sample will collected from preterm infants by a neonatal nurse. The concentration of salivary cortisol will be measured using by radioimmunoassay.
Measured: From 3 days of life (baseline) to 7 days of life
Secondary outcomes (4)
Changes on the level of cortisol during heel lancet
At 7 days of life, saliva sample will collected from preterm infants by a neonatal nurse before and 30 mins after heel lancet.
Measured: At the preterm infants 7 days of life
Score of Edinburgh Postnatal Depression Scale
Mothers' depression status will be measure by Edinburgh Postnatal Depression Scale through WeChat at discharge day. The questionnaire is a self screening tool, contains 10 items, each item is scored from 0-3 according to a 4-point Likert scale , and the total score is 0-30 points. The higher the score, the more severe the depression. All the questionnaires will collect and calculate by a neonatal nurse.
Measured: Through study completion, an average of 40 days
Length of hospital stays
Duration of hospitalization will calculate from the date of admission to the date of discharge, which obtained from clinical records files.
Measured: Through study completion, an average of 40 days
Crying time
At 7 days of life, crying time will be recorded and calculated by a neonatal nurse during heel lancet.
Measured: At the preterm infants 7 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start1 Dec 2025 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Why it stopped: The researcher in charge has left the affiliation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaojing Hu, Principal investigator, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503238
- Sponsor's protocol ID
- 2022 -31
- Status last verified
- Feb 2025
- First submitted
- 31 Jul 2022
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mother-infant Skin-to-skin Contact on Cumulative Stress of Preterm Infants in the Neonatal Intensive Care Unit : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05503238
- Acronym / sponsor ID
- 2022 -31
- Conditions
- Preterm Infant
- Keywords
- Stress response, Skin-to-skin contact, Cortisol
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The researcher in charge has left the affiliation.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 16 Aug 2022 (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.
This study will evaluate the effect of maternal-infant skin-to-skin contact (SSC) versus routine care on general stress in preterm infants in the neonatal intensive care unit (NICU).
Detailed description
Primary outcome of this trial to investigate the effects daily skin-to-skin contact on cumulative stress through measures salivary cortisol. The intervention group will receive mother-infant skin-to-skin contact at least 1 continuous hour everyday from infant 3 days of life until discharge. The control group will receive routine neonatal care during hospitalization except skin-to-skin contact. The concentration of salivary cortisol and other infant and parental outcomes will be measured in both groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Skin-to-skin contact group | Experimental | Behavioral: Skin-to-skin contact, Other: Routine careProvide maternal-infant skin-to-skin contact for preterm infants in the neonatal intensive care unit. |
| Routine care group | Other | Other: Routine carePerform routine nursing care for preterm infants in the neonatal intensive care unit. |
Who may qualify
- Ages
- 0 to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 31 weeks≤gestational age<37 weeks;
- Birth weight ≥ 1500g;
- Admission age < 24h;
- No congenital malformations;
- Vital signs are stable and does not use ventilator and other auxiliary life support systems.
Key exclusion criteria (3 listed)
- Severe periventricular / intraventricular hemorrhage (grade III);
- Receiving sedation or vasopressor or analgesics opiodis and corticosteroids;
- Mother unable to communicate and communicate normally; Mother has a history of depression.
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 contactPreterm infants will receive maternal-infant skin-to-skin contact at least 1 continuous hour everyday from infant 3 days of life until discharge, and other nursing care will be same as the routine group. During skin-to-skin contact, place naked baby only with diaper on the mother's bare chest in an upright position and tilt the baby's head to one side in a slightly extended position to keeps the airway open, cover the infant with a blanket to keep them warm. A neonatal nurse will be stay with mother and infant to observe and support. | Behavioural | Skin-to-skin contact group |
| Routine carePreterm infants will receive standard nursing care provided by neonatal nurses in accordance with hospital principles during hospitalization. | Other | Routine care group, Skin-to-skin contact group |
Primary outcome
Changes on the concentration of cortisol of preterm infants
Time frame: From 3 days of life (baseline) to 7 days of life
At 3 days of life (baseline) and 7 days of life, the saliva sample will collected from preterm infants by a neonatal nurse. The concentration of salivary cortisol will be measured using by radioimmunoassay.
4 secondary outcomes
Changes on the level of cortisol during heel lancet
Time frame: At the preterm infants 7 days of life
Score of Edinburgh Postnatal Depression Scale
Time frame: Through study completion, an average of 40 days
Length of hospital stays
Time frame: Through study completion, an average of 40 days
Crying time
Time frame: At the preterm infants 7 days of life
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Xiaojing Hu principal investigator
Children's Hospital of Fudan University
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 and Routine care in people with Preterm Infant, run by Children's Hospital of Fudan University at 1 site in China.
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 5 inclusion and 3 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: withdrawn, as of the sponsor's last update on 24 Feb 2025. 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 China. 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 was withdrawn before enrolling participants, so there are no results.
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?
Changes on the concentration of cortisol of preterm infants (time frame: From 3 days of life (baseline) to 7 days of life). 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 24 Feb 2025.