White Cover & Massage Impact on Bilirubin Levels & Phototherapy Duration

Status Recruiting

Clinical Trial Summary

This study aimed to examine the effect of white cover and massage application on newborns' bilirubin level and duration of phototherapy in newborns receiving phototherapy.

Clinical Trial Description

Hyperbilirubinemia is a common problem seen in the neonatal period, characterized by yellow staining of the skin and sclera, causing an increase in total serum bilirubin >5 mg/dl. Neonatal jaundice is seen in 60% of term newborns and 80% of preterm newborns. Hyperbilirubinemia is usually physiological and disappears within a few days. Jaundice may worsen and lead to kernicterus (accumulation of bilirubin in some parts of the brain) or death if pathological hyperbilirubinemia occurs. Therefore, every baby with hyperbilirubinemia and high serum bilirubin levels requires serious attention and treatment. The primary treatment for neonatal jaundice is phototherapy. The effectiveness of phototherapy depends on the phototherapy light source, light intensity, distance between the phototherapy light and the newborn, and the body surface area exposed to the light. Phototherapy has potential side effects in newborns such as hyperthermia, dehydration, diarrhea, bronze baby syndrome, and skin burns. For this reason, the use of phototherapy should be minimized and solutions should be found to shorten the duration of phototherapy. To increase the effectiveness of phototherapy treatment, a reflector material can be added to the phototherapy. White fabric, which can be used as a reflector, can reflect scattered phototherapy light. When fabrics made of reflective materials are hung over the phototherapy device, they can capture the light that may scatter from the baby to the environment and reflect the light back to the baby. White fabric may increase irradiance and therefore lead to increased bilirubin conversion.Studies have reported that massage applied before phototherapy is effective in reducing the bilirubin level in babies with hyperbilirubinemia. Bilirubin is eliminated from the body through defecation. Removing bilirubin from the body reduces jaundice. Massage reduces bilirubin levels by increasing the frequency of bowel movements in newborn babies. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06209489
Study type	Interventional
Source	Karabuk University
Contact
Status	Recruiting
Phase	N/A
Start date	March 1, 2024
Completion date	July 25, 2024

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT04868019` - Role of Fenofibrate in Indirect Neonatal Hyperbilirubinemia: a Randomized Control Trial	N/A
Completed	`NCT00114543` - Trial of Aggressive Versus Conservative Phototherapy in Infants <1,000 Grams Birth Weight	Phase 3
Completed	`NCT02000830` - Follow up Study of Patients Having Participated in Clinical Trial 64,185-204
Completed	`NCT01887327` - Stannsoporfin With Light Therapy for Newborn Babies With Jaundice	Phase 2
Completed	`NCT05356273` - The Effect of Massage on the Bilirubin Level in Term Infants Receiving Phototherapy	N/A
Suspended	`NCT03741803` - Relationship Between Delayed Cord Clamping at Birth and Neonatal Bilirubin Levels in Parturients With a Prior Child Requiring Therapy for Neonatal Jaundice	N/A
Recruiting	`NCT03876678` - The Efficacy of Oral Probiotics on Neonatal Hyperbilirubinemia	N/A
Not yet recruiting	`NCT05365984` - Intelligent Follow-up of Neonatal Jaundice Based on Early Indicators and Internet Communications	N/A
Recruiting	`NCT04251286` - Screening and Follow-up Study of Neonatal Jaundice Based on Mobile Network
Completed	`NCT03723005` - A Light Emitting Diode (LED) Mattress for Phototherapy of Jaundiced Newborns
Recruiting	`NCT06087874` - Preventive Effect of Perinatal Oral Probiotic Supplementation (POPS) on Neonatal Jaundice	Phase 2
Completed	`NCT03624335` - Influence of Umbilical Cord Clamping Time in the Newborn	N/A
Recruiting	`NCT06324799` - The Effect of Position Change Frequency on Hyperbilirubinemia	N/A
Completed	`NCT03824990` - Multi-center Clinical Study on Neonatal Hyperbilirubinemia	N/A
Withdrawn	`NCT01330667` - Effect of Early Limited Formula on Total Serum Bilirubin Among Newborns With Hyperbilirubinemia	N/A
Completed	`NCT01169740` - Transcutaneous Measurement of Jaundice in the Newborn	N/A
Recruiting	`NCT06238349` - Hyperbilirubinemia in Full-term Neonates	Phase 4
Completed	`NCT03007563` - Evaluation of a Smartphone Based Optical Diagnostic Tool for Neonatal Jaundice	N/A
Completed	`NCT01762189` - The Incidence and Risk Factors of Neonatal Hyperbilirubinemia in Term and Late-preterm Chinese Infants	N/A
Completed	`NCT01763632` - Development of TcB Nomogram to Identify Neonatal Hyperbilirubinemia in Term and Late-preterm Infants	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

White Cover and Massage Impact on Bilirubin Levels and Phototherapy Duration in Newborns

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms