Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-06-21 @ 4:02 PM
Study NCT ID:
NCT07386093
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-04
First Post:
2026-01-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief 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
Sponsor:
Istanbul University - Cerrahpasa
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: