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Clinical Trials/NCT04287322
NCT04287322
Completed
Not Applicable

Effect of Auditory and Tactile-kinesthetic Stimulation on Physiological Parameters, Physical Growth and Behaviour of Preterm Neonates

Moi University1 site in 1 country108 target enrollmentJanuary 14, 2018
ConditionsPrematurity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prematurity
Sponsor
Moi University
Enrollment
108
Locations
1
Primary Endpoint
Weight
Status
Completed
Last Updated
6 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
January 14, 2018
End Date
January 28, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

CONSTANTINE OLIEBA AKWANALO

Clinical consultant

Moi University

Eligibility Criteria

Inclusion Criteria

  • on breast milk or formula feeds
  • born 28 to 37 weeks gestational age
  • ≥1000grams. The gestation was limited to ≥ 28 weeks and ≥1000grams based on significant neonatal mortality rate in neonates born before 28 weeks gestation and/or weighing \<1000grams in MTRH (Njuguna et al., 2015).

Exclusion Criteria

  • critically ill and those on continuous positive airway pressure (CPAP)
  • had neonatal infections including severe sepsis or necrotizing enterocolitis.

Outcomes

Primary Outcomes

Weight

Time Frame: 21 days

Preterm neonates were weighed without clothes on ade digital weighing scale by the research assistants. The scale was disinfected, rechecked and caliberated to zero before each measurement.

Oxygen saturation

Time Frame: 15 minutes

The preterm neonate was connected to a cardio-respiratory monitor (CODEC patient monitor CMS6000) and oxygen saturation readings were recorded by research assistant.

Heart rate

Time Frame: 15 minutes

The preterm neonate was connected to a cardio-respiratory monitor (CODEC patient monitor CMS6000) and heart rate readings were recorded by research assistants.

Respiratory rate was measured by counting breaths per minute by the research assistants.

Time Frame: 15 minutes

Recording respiratory rate

Body temperature

Time Frame: 15 minutes

The preterm neonate was connected to a cardio-respiratory monitor (CODEC patient monitor CMS6000) with a temperature probe and temperature readings were recorded by research assistants.

Behavioral development

Time Frame: 21 days

Neonatal Behavioral Assessment Scale by Brazelton TB \& Nugent J., (2011) was administered to each preterm neonate in the study by a trained research assistant. Minimum score was 1 and maximum score 9, a higher score indicated better behavioral development of preterm neonate.

Study Sites (1)

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