Tactile and Kinaesthetic Stimulation in Neonates With Hyperbilirubinaemia

Neonatal Hyperbilirubinemia Clinical Trial

Official title:

Tactile and Kinaesthetic Stimulation in Preterm Neonates With Hyperbilirubinaemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05077787
• Other study ID #: U1111-1269-9921
• Status: Completed
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: January 11, 2024

Study information

• Verified date: January 2024
• Source: Maharishi Markendeswar University (Deemed to be University)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hyperbilirubinemia is the most common problem seen in neonates, owing to severe complications in their lifetime. The study design of the study is pretest - a posttest experimental design. Criterion-based purposive sampling will be used for recruiting the neonates. In the study neonates will be selected according to the selection criteria and will be allocated into two groups using computer-based randomization.The Intervention group - neonates will receive tactile and kinesthetic stimulation for 15 minutes for 3 consecutive days, 1 hour after feeding twice daily along with Phototherapy, Control group - Phototherapy alone will be given along with conventional NICU care. Total serum bilirubin will be assessed as outcome measures daily once. Transcutaneous bilirubin will be assessed after every intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: January 11, 2024
• Est. primary completion date: January 11, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Hours to 10 Days

Eligibility

1. New born in Neonatal Intensive Care Unit

2. Stable vitals

3. Full Term and Preterm neonates

4. Gestational age 34 weeks to 40 weeks

5. Birth weight -1800 - 3000 g

6. APGAR Score at birth of 8 -10

7. Total serum bilirubin levels > 10 mg/dL

Related Conditions & MeSH terms

• Hyperbilirubinemia
• Hyperbilirubinemia, Neonatal
• Neonatal Hyperbilirubinemia

Intervention

Other:
• Massage therapy
Massage therapy includes stroking, kneading, rolling, tapping, vibration and effleurage over the face, chest ,abdomen and back. Massage therapy will be given for 5 minutes and will be repeated twice.
• Kinaesthetic stimulation
Kinaesthetic stimulation includes passive flexion and extension movements of shoulder joint, elbow joint, hip joint, knee joint and both lower limbs together. It will be given for 5 minutes in each intervention

Locations

Country	Name	City	State
India	Civil Hospital	Ropar	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Asir John Samuel

Country where clinical trial is conducted

India, 

References & Publications (4)

Field T. Pediatric Massage Therapy Research: A Narrative Review. Children (Basel). 2019 Jun 6;6(6):78. doi: 10.3390/children6060078. — View Citation

Lin CH, Yang HC, Cheng CS, Yen CE. Effects of infant massage on jaundiced neonates undergoing phototherapy. Ital J Pediatr. 2015 Nov 25;41:94. doi: 10.1186/s13052-015-0202-y. — View Citation

Niemi AK. Review of Randomized Controlled Trials of Massage in Preterm Infants. Children (Basel). 2017 Apr 3;4(4):21. doi: 10.3390/children4040021. — View Citation

Rahmawati D, Sampurna MTA, Etika R, Utomo MT, Bos AF. Transcutaneous bilirubin level to predict hyperbilirubinemia in preterm neonates. F1000Res. 2020 Apr 28;9:300. doi: 10.12688/f1000research.22264.2. eCollection 2020. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Serum Bilirubin (TSB)	It will measure total bilirubin level in blood of neonates	Changes in the Total Serum Bilirubin level will be measured at baseline and at the end of three days intervention
Primary	Transcutaneous Bilirubin (TcB)	Transcutaneous Bilirubin will measure neonatal jaundice.	Changes in the Transcutaneous Bilirubin level will be measured daily for three days before and after intervention
Primary	Weight Gain	Weight gain will evaluate the change in neonatal weight	Changes in the weight will be measured at baseline and at the end of three days intervention