Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Recruiting Not applicable

Effect of Bathing on Physiological Parameters, Skin, Bilirubin and Comfort Levels in Infants Receiving Phototherapy

NCT06819150 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2024-05-01
Last updated
2025-02-11

Condition(s) studied

Phototherapy Skin Rash

Investigational drug(s) / intervention(s)

Newborn bathing

Newborn bathing: The babies in the experimental group will have a bathtub bath before starting phototherapy treatment.

Study summary

The aim of this study is to determine the effect of bathing on physiological parameters (heart rate, body temperature and oxygen saturation), skin, bilirubin and comfort level in infants receiving phototherapy.

Eligibility

Sex
ALL
Min age
1 Day
Max age
28 Days
Healthy volunteers
No
Inclusion Criteria: * Born at 35-41 gestational weeks * Indirect hyperbilirubinaemia diagnosed at 24 hours of birth or more, * No health problems, * Indication for phototherapy treatment * Stable vital signs * Whose parents agreed to participate in the study Exclusion Criteria: * Newborns with ABO and Rh incompatibility, * Direct diagnosis of hyperbilirubinaemia, * Congenital anomaly, * With skin lesions

Primary outcome measure(s)

  • Infant Information Form — First measurement-First day of hospitalization
    The form, prepared by the researchers based on the literature, includes questions containing natal-postnatal information of preterm and term infants (date of birth, gestational week, postnatal age, gender, birth weight, mode of delivery, NICU admission date, initiation time of phototherapy, etc.).
  • Follow-up form for physiologic parameters - Heart rate — Heart rate will be measured 10 minutes before the intervention (T0), 30 minutes (T1), 60 minutes (T2) and 6 hours (T3) after the intervention.
    Heart rate will be measured 10 minutes before the intervention, 30 minutes, 60 minutes and 6 hours after the intervention.
  • Follow-up form for physiologic parameters -Respiratory rate — Respiratory rate will be measured 10 minutes before the intervention (T0), 30 minutes (T1), 60 minutes (T2) and 6 hours (T3) after the intervention.
    Respiratory rate will be measured 10 minutes before the intervention, 30 minutes, 60 minutes and 6 hours after the intervention.
  • Follow-up form for physiologic parameters- Body temperature — Body temperature will be measured 10 minutes before the intervention (T0), 30 minutes (T1), 60 minutes (T2) and 6 hours (T3) after the intervention.
    Body temperature will be measured 10 minutes before the intervention, 30 minutes, 60 minutes and 6 hours after the intervention.
  • Follow-up form for physiologic parameters- Oxygen saturation — Oxygen saturation will be measured 10 minutes before the intervention (T0), 30 minutes (T1), 60 minutes (T2) and 6 hours (T3) after the intervention.
    Oxygen saturation will be measured 10 minutes before the intervention, 30 minutes, 60 minutes and 6 hours after the intervention.
  • Follow-up form for Skin moisture — Skin moisture will be measured 10 minutes before the intervention (T0), 30 minutes (T1), 60 minutes (T2) and 6 hours (T3) after the intervention.
    Skin moisture will be measured using a device (Digital Moisture Monitor for Skin) on the forehead, abdomen, back, arms (right-left) and legs (right-left).
  • Neonatal Skin Condition Score — Neonatal Skin Condition Assessment Scale, will assess the infants' skin condition 10 minutes before treatment/bath (T0) The infants' skin condition will then be reassessed 30 minutes (T1), 60 minutes (T2) and 6 hours (T3) after bath or treatment.
    Neonatal Skin Condition Assessment Scale, will assess the infants' skin condition 10 minutes before treatment/bath (T0) The infants' skin condition will then be reassessed 30 minutes (T1), 60 minutes (T2) and 6 hours (T3) after bath or treatment.
  • Bilirubin level — In the experimental and control groups, the total serum bilirubin levels will be evaluated 10 minutes before treatment/bathing (T0). The bilirubin levels will be measured for the second time at 24 hours after the start of phototherapy treatment (T1).
    In the experimental and control groups, the total serum bilirubin levels will be evaluated 10 minutes before treatment/bathing (T0). The bilirubin levels will be measured for the second time at 24 hours after the start of phototherapy treatment (T1).
  • The comfort level — The comfort level of the babies in the experimental and control groups will be evaluated 10 minutes before the treatment/bath. The comfort of the babies will be re-evaluated 30 minutes (T1), 60 minutes (T2) and 6 hours (T3) after the bath or treatment.
    The Newborn Comfort Behavior Scale (COMFORTneo) will assess the comfort of the newborn. The scale will evaluate the newborn's calmness/agitation, respiratory response, pain, body movements, facial tension, and muscle tone.The scale is scored between 6-30. As the score obtained from the scale increases, it shows that the newborn is uncomfortable and needs practices that will increase their comfort

Trial sites (1)

FacilityCityRegionStatus
Kütahya Şehir Hospital Kütahya Merkez Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06819150 on ClinicalTrials.gov ↗ ← All trials in Turkey