NCT07386093

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Jan 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress67%
Jan 2026Jun 2026

First Submitted

Initial submission to the registry

January 19, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

January 20, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

February 4, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

January 19, 2026

Last Update Submit

January 27, 2026

Conditions

Keywords

newbornneonatal jaundice

Outcome Measures

Primary Outcomes (1)

  • 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.

    One month

Secondary Outcomes (3)

  • Bristol Lactation Assessment Tool (BEDS)

    one month

  • Newborn Monitoring Form

    one month

  • S-card Parent Feedback Evaluation Form:

    one month

Study Arms (2)

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.

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.

Other: control group

Interventions

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.

The group using the Skin Color Scale Material (S-CARD / Neonatal Jaundice Monitoring Card).

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.

Group not using Skin Color Scale Material (S-CARD / Neonatal Jaundice Monitoring Card)

Eligibility Criteria

Age36 Weeks - 42 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Jaundice, Neonatal

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Hyperbilirubinemia, NeonatalInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperbilirubinemiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
midwife

Study Record Dates

First Submitted

January 19, 2026

First Posted

February 4, 2026

Study Start

January 20, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

February 4, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share