Effect of Auditory & Tactile-kinesthetic Stimulation on Preterm Neonates

Status Completed

Clinical Trial Summary

The study was conducted at a level II special care nursery of the Moi Teaching & Referral Hospital, an academic hospital in the Western region of Kenya. A sample of 108 preterm neonates who met eligibility criteria were studied (36 in auditory group, 36 in tactile-kinesthetic stimulation group, and 36 in control group). Auditory group listened to recorded maternal voice while tactile-kinesthetic group received massage and joint movements.The interventions were provided for 15 minutes, 3 times a day for 10 days while outcome measures were observed for 21 days. The neonates in the control group received standard neonatal care and were observed for outcome measures as those in the intervention groups.

Clinical Trial Description

The study was aimed to determine the effect of auditory stimulation using recorded maternal voice and tactile-kinesthetic stimulation on physiological parameters, physical growth and behavioral development of preterm neonates. Three groups were involved; auditory stimulation, tactile-kinesthetic stimulation and control.

A quasi-experimental design was used to recruit 108 study subjects (36 in each group). A trained researcher conducted the stimulation in the intervention groups and two research assistants did the data entry. The research assistants were blinded to aim of study, group assignments, and interventions received by preterm neonates.

Preterm neonates baseline characteristics and clinical data were obtained at initial contact.

Physiological parameters (heart rate, oxygen saturation and body temperature) were monitored using a cardio-respiratory monitor (CODEC patient monitor CMS6000). Respiratory rate was measured by counting breaths per minute by the research assistant. The parameters were monitored and recorded before, during and after stimulation in the intervention groups. The control group had the measurement recorded in the morning, afternoon and evening.

Physical growth was assessed using weight measurement. Neonates are weighed daily in the nursery and data on weight was entered by research assistants on alternate days.

Neonatal behavioral assessment scale (NBAS) was used to assess behavior at initial contact, day 10, 17 and 24. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04287322
Study type	Interventional
Source	Moi University
Contact
Status	Completed
Phase	N/A
Start date	January 14, 2018
Completion date	January 28, 2019

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03670732` - CPAP vs.Unsynchronized NIPPV at Equal Mean Airway Pressure	N/A
Completed	`NCT05322161` - Yoga in the NICU for Parents Study	N/A
Recruiting	`NCT04542096` - Real Time Evaluation of Dynamic Changes of the Lungs During Respiratory Support of VLBW Neonates Using EIT
Recruiting	`NCT04911452` - Creating a Calmer NICU: Optimizing Growth and Brain Development in Preterm Infants	N/A
Recruiting	`NCT02901652` - NIPPV and nBiPAP Methods in Preterm Infants With Respiratory Distress Syndrome	N/A
Completed	`NCT02148965` - Effects of Exercise During Pregnancy on Maternal and Child Health: a Randomized Clinical Trial	N/A
Terminated	`NCT02032511` - Comparison of RAM Cannula Nasal Continuous Positive Airway Pressure Versus Infant Flow Nasal Continuous Positive Airway Pressure (NCPAP)	N/A
Completed	`NCT02273843` - A Trial on Different Dosages of Vitamin D in Preterm Infants With Late-onset Sepsis	Phase 1
Completed	`NCT01721629` - Weaning of Nasal Continuous Positive Airway Pressure (CPAP) in Premature Infants	N/A
Terminated	`NCT01819532` - Milking the Umbilical Cord Versus Immediate Clamping in Pre-term Infants < 33 Weeks	N/A
Completed	`NCT01478711` - Comprehensive Clinical Decision Support (CDS) for the Primary Care of Premature Infants	N/A
Completed	`NCT01523769` - Umbilical Cord Milking on the Reduction of Red Blood Cell Transfusion Rates in Infants	N/A
Completed	`NCT00951860` - Assessment of Autonomic Maturation in Neonatal Period and Early Neural Development From a Longitudinal Prospective Cohort	N/A
Completed	`NCT00749008` - Study of Generalized Movements for Early Prediction of Cerebral Palsy	N/A
Completed	`NCT00787124` - Transfusions and Nitric Oxide Level in Preterm Infants
Terminated	`NCT01208493` - Dietary Protein in the Very-low-birth-weight Infant	N/A
Completed	`NCT00527956` - Facilitation and Barriers to Breastfeeding in the NICU	N/A
Terminated	`NCT00486395` - Will CPAP Reduce Length Of Respiratory Support In Premature Infants?	Phase 3
Completed	`NCT03372590` - NEO Rehab for Infants at Risk of Cerebral Palsy	N/A
Completed	`NCT00033917` - Indomethacin Germinal Matrix Hemorrhage/Intraventricular Hemorrhage (GMH/IVH) Prevention Trial	Phase 3

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.

Effect of Auditory and Tactile-kinesthetic Stimulation on Preterm Neonates

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms