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CompletedNCT05077787Updated Jan 29, 2024

Tactile and Kinaesthetic Stimulation in Neonates With Hyperbilirubinaemia

An interventional study of Massage therapy and Kinaesthetic stimulation in Neonatal Hyperbilirubinemia, sponsored by Asir John Samuel. Completed at 1 site in India. Open to participants aged 24 Hours to 10 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-29.

Sponsored by Asir John Samuel · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
24 Hours to 10 Days
Sex
All
01

Study 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.

02

Conditions studied

  • Neonatal Hyperbilirubinemia
03

In context

Hyperbilirubinemia, Neonatal

93 studies on the registry are indexed under Hyperbilirubinemia, Neonatal; 20 are open to participants now.

This study's enrollment of 68 is below the median of 94 across 59 interventional studies indexed under Hyperbilirubinemia, Neonatal.

Browse Hyperbilirubinemia, Neonatal studies →

Lead sponsor

Asir John Samuel is the lead sponsor of 26 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
24 Hours to 10 Days
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

  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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
68 participants (actual)

Study arms

  • Experimental
    Experimental Group

    Neonates recruited in experimental group will receive massage therapy and kinaesthetic stimulation for 15 minutes along with phototherapy for consecutive days . It will be given in three phases first massage therapy will be given for 5 minutes, followed by movement of limbs for 5 minutes and then again massage therapy will be repeated for 5 minutes.

    Other: Massage therapy · Other: Kinaesthetic stimulation

  • No intervention
    Control Group

    Neonates recruited in control group will receive phototherapy alone along with regular care

Interventions

  • OtherMassage 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.

  • OtherKinaesthetic 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

06

What researchers measure

Primary outcomes

  1. Total Serum Bilirubin (TSB)

    It will measure total bilirubin level in blood of neonates

    Time frame: Changes in the Total Serum Bilirubin level will be measured at baseline and at the end of three days intervention

  2. Transcutaneous Bilirubin (TcB)

    Transcutaneous Bilirubin will measure neonatal jaundice.

    Time frame: Changes in the Transcutaneous Bilirubin level will be measured daily for three days before and after intervention

  3. Weight Gain

    Weight gain will evaluate the change in neonatal weight

    Time frame: Changes in the weight will be measured at baseline and at the end of three days intervention

07

Study locations

1 site
  • Civil Hospital
    Ropar, Punjab 140001, India
08

References and documents

Publications

  • 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. PubMed 33014346 ↗
  • 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. PubMed 26607061 ↗
  • Field T. Pediatric Massage Therapy Research: A Narrative Review. Children (Basel). 2019 Jun 6;6(6):78. doi: 10.3390/children6060078. PubMed 31174382 ↗
  • Niemi AK. Review of Randomized Controlled Trials of Massage in Preterm Infants. Children (Basel). 2017 Apr 3;4(4):21. doi: 10.3390/children4040021. PubMed 28368368 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05077787
Lead sponsor
Asir John Samuel
Responsible party
Asir John Samuel (Associate Professor, Maharishi Markendeswar University (Deemed to be University)) — Sponsor-investigator
First posted
Oct 14, 2021
Start date
Apr 1, 2022
Primary completion
Jan 11, 2024
Completion
Jan 11, 2024
Last update
Jan 29, 2024

Study contacts

Saumya Kothiyal, MPT
principal investigator · Maharishi Markendeshawar (Deemed to be University)

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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