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OpenTrials
Completed

NCT Number: NCT05077787

Tactile and Kinaesthetic Stimulation in Neonates With Hyperbilirubinaemia

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.

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Key information

Conditions

Neonatal Hyperbilirubinemia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hyperbilirubinemia Hyperbilirubinemia, Neonatal Infant, Newborn, Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

24 hour–10 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Civil Hospital

Ropar, Punjab, 140001, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • New born in Neonatal Intensive Care Unit
  • Stable vitals
  • Full Term and Preterm neonates
  • Gestational age 34 weeks to 40 weeks
  • Birth weight -1800 - 3000 g
  • APGAR Score at birth of 8 -10
  • Total serum bilirubin levels > 10 mg/dL

Treatment and study plan

Massage therapy

Other

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

Other

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

Primary outcomes

  1. Total Serum Bilirubin (TSB)

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

    It will measure total bilirubin level in blood of neonates

  2. Transcutaneous Bilirubin (TcB)

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

    Transcutaneous Bilirubin will measure neonatal jaundice.

  3. Weight Gain

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

    Weight gain will evaluate the change in neonatal weight

Sponsors and collaborators

Lead sponsor

Asir John Samuel

Other

Registry information

Official study title

Tactile and Kinaesthetic Stimulation in Preterm Neonates With Hyperbilirubinaemia

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 14, 2021
Registry last updated
Jan 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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