Clinical trial NCT04287322: Effect of Auditory and Tactile-kinesthetic Stimulation on Preterm Neonates
Official title: Effect of Auditory and Tactile-kinesthetic Stimulation on Physiological Parameters, Physical Growth and Behaviour of Preterm Neonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prematurity
Keywords: Maternal voice and tactile-kinesthetic stimulation
Lead sponsor: Moi University
Sponsor class: OTHER
Collaborators: name: Alexandria University
First posted: 2020-02-27
Enrollment: 108
Sex: ALL
Minimum age (years): 3
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Quasi-experimental design
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Oxygen saturation
timeFrame: 15 minutes
measure: Heart rate
timeFrame: 15 minutes
measure: Respiratory rate was measured by counting breaths per minute by the research assistants.
timeFrame: 15 minutes
measure: Body temperature
timeFrame: 15 minutes
measure: Weight
timeFrame: 21 days
measure: Behavioral development
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Eldoret
country: Kenya
facility: Constantine Akwanalo
Study officials:
affiliation: Moi University
name: Fabian Esamai, PhD
role: STUDY_CHAIR
References: