Neonatal JaundiceNCT07386093
The Effect of Skin Color Scale Material Used by Families at Home in the Postnatal Period on the Process of Hospital Admission Due to Jaundice and Breastfeeding Parameters
A study testing Experiment Group in people with Neonatal Jaundice, run by Istanbul University - Cerrahpasa.
Trial summary
The aim of this research is to evaluate the effect of the Skin Color Scale Material used by families in the postnatal period on the hospital admission process due to jaundice and breastfeeding parameters. Read more about this study
- Who is it for?
- Ages 36 to 42 weeksHealthy volunteers can take part
- Conditions the study is for
- Neonatal Jaundice
- What is being tested?
- Experiment Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2026to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 36 to 42 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preterm infants born alive between 36-42 weeks of gestation or delivered healthy to their mothers,
- Newborns with a birth weight of 2500 grams or more,
- Newborns without a history of multiple pregnancy (twins, triplets, etc.),
- Newborns with at least one literate parent,
- Newborns whose families voluntarily agree to participate in the study and sign the informed consent form.
Who cannot join
- Newborns younger than 36 weeks and requiring intensive care, or newborns older than 42 weeks,
- Newborns weighing less than 2500 grams at birth,
- Newborns requiring postnatal intensive care,
- Newborns with congenital anomalies, metabolic diseases, or serious clinical problems,
- Newborns whose families wish to withdraw from the study during the follow-up period or whose contact information is unavailable,
- Newborns excluded from analysis due to incomplete or erroneous data,
- Newborns whose families did not sign the informed consent form.
About this study
The aim of this research is to evaluate the effect of the Skin Color Scale Material used by families in the postnatal period on the hospital admission process due to jaundice and breastfeeding parameters.
Although neonatal jaundice is mostly physiological, it can lead to serious complications such as kernicterus if not detected in time. Visually supported educational materials developed to provide early awareness can help families both to regularly monitor the baby's skin color and to notice the signs of jaundice in time.
Read the detailed description
The Skin Color Scale Material (S-CARD / Neonatal Jaundice Monitoring Card), developed within the scope of this study, is a unique material based on visual assessment of skin color. The material includes 6 color ranges adapted from the Bili-ruler reference, with spaces reserved for observation and guiding statements to indicate the risk level opposite each color. With these features, it makes it possible for parents and healthcare professionals to easily visually detect jaundice. A user guide has also been prepared to support the correct and safe use of the card. The guide, which includes 6 instructions explaining the use of the card step by step and 5 warning notes for possible symptoms, not only provides a visual scale but also functions as a user-friendly and reliable guide. The research will be conducted through experimental and control groups determined by random assignment. Parents in the experimental group will be given detailed information about the use of the Skin Color Scale Material (S-CARD / Neonatal Jaundice Monitoring Card); Parents will be asked to observe their babies' skin color daily for the first 7 days after birth and compare their observations with the card. The control group will only receive standard verbal information at discharge, as already applied in the unit. In both groups, breastfeeding parameters (frequency, duration, general condition after breastfeeding) will be monitored on the 3rd and 7th days after discharge. The sample of the study consists of newborns with a birth weight ≥2500 grams, born between 36-42 weeks, without multiple pregnancies, and at least one parent who is literate, along with their parents. Participant selection will be made from among newborns and parents who meet the eligibility criteria. Data will be collected using the Personal Information Form, Newborn Monitoring Form, Skin Color Scale Material (S-CARD / Newborn Jaundice Monitoring Card), Parent Opinion Assessment Form, and Bristol Breastfeeding Assessment Tool developed by the researcher.
- Conditions
- Neonatal Jaundice
- Being tested
- Experiment Group, control group
- Keywords
- newborn, neonatal jaundice
- Medical subject headings
- Jaundice, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experiment GroupOther
The Skin Color Scale Material (S-CARD / Neonatal Jaundice Monitoring Card) developed by the researcher and its user guide will be provided; verbal and visual training on the use of the material will be provided. Parents will be asked to observe their baby's skin color for the first 7 days after birth and record it on the monitoring card.
control groupOther
Families in this group will only receive routine, verbal information from the unit upon discharge. Both groups will be monitored similarly, but training on the use of the Skin Color Scale Material (S-CARD / Neonatal Jaundice Monitoring Card) will only be given to the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| The group using the Skin Color Scale Material (S-CARD / Neonatal Jaundice Monitoring Card). | Experimental | The Skin Color Scale Material (S-CARD / Neonatal Jaundice Monitoring Card) developed by the researcher and its user guide will be provided; verbal and visual training on the use of the material will be provided. Parents will be asked to observe their baby's skin color for the first 7 days after birth and record it on the monitoring card. Receives: Other: Experiment Group |
| Group not using Skin Color Scale Material (S-CARD / Neonatal Jaundice Monitoring Card) | Active comparator | Families in this group will only receive routine, verbal information from the unit upon discharge. Both groups will be monitored similarly, but training on the use of the Skin Color Scale Material (S-CARD / Neonatal Jaundice Monitoring Card) will only be given to the experimental group. Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data Collection Form
Developed by the researcher and their consultant in line with the literature (source). It is a form consisting of 34 questions. Participants' demographic characteristics, obstetric history, and information regarding childbirth will be obtained through this form.
Measured: One month
Secondary outcomes (3)
Bristol Lactation Assessment Tool (BEDS)
This is a form developed by Jenny Ingram in 2014 and validated in Turkish by Dolgun et al. in 2018. The application time for the scale is 5-10 minutes. While the Cronbach alpha value of the original form of the instrument was found to be 0.68, it was found to be 0.77 in the Turkish adaptation study. Scoring of the scale:
Each item is scored between 0-2 points. The lowest score obtained from the scale is 0, and the highest score is 8. It will be used to evaluate the breastfeeding success of babies. This instrument covers parameters such as breastfeeding frequency, duration, time of initiation of breastfeeding, and the general condition of the baby.
Measured: one month
Newborn Monitoring Form
This is a chart consisting of 7 questions developed by the researcher and their advisor in line with the literature. Data regarding the clinical follow-up period of the infants included in the study will be recorded in this form.
Measured: one month
S-card Parent Feedback Evaluation Form:
It is a form consisting of 14 questions developed by the researcher and his/her advisor in line with the literature.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start20 Jan 2026 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal JaundiceStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Crossover
- Model description
- The Skin Color Scale Material (S-CARD / Neonatal Jaundice Monitoring Card) developed by the researcher and its user guide will be provided; verbal and visual training on the use of the material will be provided. Parents will be asked to observe their baby's skin color for the first 7 days after birth and record it on the monitoring card.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neva Çöpden, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07386093
- Sponsor's protocol ID
- IUC-GEI-NC-01
- Status last verified
- Jan 2026
- First submitted
- 19 Jan 2026
- Last updated
- 4 Feb 2026
- 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 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Skin Color Scale Material Used by Families at Home in the Postnatal Period on the Process of Hospital Admission Due to Jaundice and Breastfeeding Parameters
- ClinicalTrials.gov ID
- NCT07386093
- Acronym / sponsor ID
- IUC-GEI-NC-01
- Conditions
- Neonatal Jaundice
- Keywords
- newborn, neonatal jaundice
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 20 Jan 2026 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 4 Feb 2026 (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.
The aim of this research is to evaluate the effect of the Skin Color Scale Material used by families in the postnatal period on the hospital admission process due to jaundice and breastfeeding parameters.
Although neonatal jaundice is mostly physiological, it can lead to serious complications such as kernicterus if not detected in time. Visually supported educational materials developed to provide early awareness can help families both to regularly monitor the baby's skin color and to notice the signs of jaundice in time.
Detailed description
The Skin Color Scale Material (S-CARD / Neonatal Jaundice Monitoring Card), developed within the scope of this study, is a unique material based on visual assessment of skin color. The material includes 6 color ranges adapted from the Bili-ruler reference, with spaces reserved for observation and guiding statements to indicate the risk level opposite each color. With these features, it makes it possible for parents and healthcare professionals to easily visually detect jaundice. A user guide has also been prepared to support the correct and safe use of the card. The guide, which includes 6 instructions explaining the use of the card step by step and 5 warning notes for possible symptoms, not only provides a visual scale but also functions as a user-friendly and reliable guide. The research will be conducted through experimental and control groups determined by random assignment. Parents in the experimental group will be given detailed information about the use of the Skin Color Scale Material (S-CARD / Neonatal Jaundice Monitoring Card); Parents will be asked to observe their babies' skin color daily for the first 7 days after birth and compare their observations with the card. The control group will only receive standard verbal information at discharge, as already applied in the unit. In both groups, breastfeeding parameters (frequency, duration, general condition after breastfeeding) will be monitored on the 3rd and 7th days after discharge. The sample of the study consists of newborns with a birth weight ≥2500 grams, born between 36-42 weeks, without multiple pregnancies, and at least one parent who is literate, along with their parents. Participant selection will be made from among newborns and parents who meet the eligibility criteria. Data will be collected using the Personal Information Form, Newborn Monitoring Form, Skin Color Scale Material (S-CARD / Newborn Jaundice Monitoring Card), Parent Opinion Assessment Form, and Bristol Breastfeeding Assessment Tool developed by the researcher.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- The Skin Color Scale Material (S-CARD / Neonatal Jaundice Monitoring Card) developed by the researcher and its user guide will be provided; verbal and visual training on the use of the material will be provided. Parents will be asked to observe their baby's skin color for the first 7 days after birth and record it on the monitoring card.
| Arm | Type | Receives |
|---|---|---|
| The group using the Skin Color Scale Material (S-CARD / Neonatal Jaundice Monitoring Card). | Experimental | Other: Experiment GroupThe Skin Color Scale Material (S-CARD / Neonatal Jaundice Monitoring Card) developed by the researcher and its user guide will be provided; verbal and visual training on the use of the material will be provided. Parents will be asked to observe their baby's skin color for the first 7 days after birth and record it on the monitoring card. |
| Group not using Skin Color Scale Material (S-CARD / Neonatal Jaundice Monitoring Card) | Active comparator | Other: control groupFamilies in this group will only receive routine, verbal information from the unit upon discharge. Both groups will be monitored similarly, but training on the use of the Skin Color Scale Material (S-CARD / Neonatal Jaundice Monitoring Card) will only be given to the experimental group. |
Who may qualify
- Ages
- 36 to 42 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Preterm infants born alive between 36-42 weeks of gestation or delivered healthy to their mothers,
- Newborns with a birth weight of 2500 grams or more,
- Newborns without a history of multiple pregnancy (twins, triplets, etc.),
- Newborns with at least one literate parent,
- Newborns whose families voluntarily agree to participate in the study and sign the informed consent form.
Key exclusion criteria (7 listed)
- Newborns younger than 36 weeks and requiring intensive care, or newborns older than 42 weeks,
- Newborns weighing less than 2500 grams at birth,
- Newborns requiring postnatal intensive care,
- Newborns with congenital anomalies, metabolic diseases, or serious clinical problems,
- Newborns whose families wish to withdraw from the study during the follow-up period or whose contact information is unavailable,
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 |
|---|---|---|
| Experiment GroupThe Skin Color Scale Material (S-CARD / Neonatal Jaundice Monitoring Card) developed by the researcher and its user guide will be provided; verbal and visual training on the use of the material will be provided. Parents will be asked to observe their baby's skin color for the first 7 days after birth and record it on the monitoring card. | Other | The group using the Skin Color Scale Material (S-CARD / Neonatal Jaundice Monitoring Card). |
| control groupFamilies in this group will only receive routine, verbal information from the unit upon discharge. Both groups will be monitored similarly, but training on the use of the Skin Color Scale Material (S-CARD / Neonatal Jaundice Monitoring Card) will only be given to the experimental group. | Other | Group not using Skin Color Scale Material (S-CARD / Neonatal Jaundice Monitoring Card) |
Primary outcome
Data Collection Form
Time frame: One month
Developed by the researcher and their consultant in line with the literature (source). It is a form consisting of 34 questions. Participants' demographic characteristics, obstetric history, and information regarding childbirth will be obtained through this form.
3 secondary outcomes
Bristol Lactation Assessment Tool (BEDS)
Time frame: one month
Newborn Monitoring Form
Time frame: one month
S-card Parent Feedback Evaluation Form:
Time frame: one month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Experiment Group in people with Neonatal Jaundice, run by Istanbul University - Cerrahpasa.
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 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: opening soon, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Data Collection Form (time frame: One month). 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 4 Feb 2026.