Effect of Tactile/Kinaesthetic Massage Therapy on Growth Parameters and Body Composition of Preterm Infants
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 3
- Primary Endpoint
- Growth parameter (Weight)
Study Overview
Brief Summary
The effect of Tactile/Kinaesthetic massage therapy on weight gain and different components of growth, as assessed by anthropometric measurements and DXA scan, and correlate these components with serum IGF-1, leptin and adiponectin in preterm infants.
Detailed Description
Prospective open label randomized, single-blind, controlled trial was done in the NICU at Mansoura University Children's Hospital.
Stable preterm infants in the NICU awaiting for sustained pattern of weight gain were included in the study.
Massage therapy was started at corrected gestational age of 35 weeks and continued for 5 consecutive days. The protocol of massage therapy was performed as been described by Tiffany Field. Three consecutive, 15 minutes, sessions were performed daily after the noon feeding. Each treatment session was divided into 5 minutes of tactile stimulation, followed by 5 minutes of kinaesthetic stimulation, and then another 5 minutes of tactile stimulation.
During massage therapy, infant's behavioural reaction was observed for signs of distress (e.g., yawning, finger splaying, crying). Vital signs are measured 15 minutes before, 15 minutes during and 15 minutes after the massage procedure. If signs of physiologic distress developed (heart rate greater than 200 bpm), massage was discontinued for 15 seconds, or until a return to baseline levels.
The study was discontinued if five periods of observed behavioural or physiological stress occurred.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 35 Weeks to 36 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Medically stable premature infants with gestational age at 28 to 37 weeks' admitted to the "grower" (step-down) nursery. Stability is defined as lack of need for supplemental oxygen, apneas and bradycardias, systemic antimicrobial therapy for infection, or a central line. On at least 100 ml/kg/d of feed (oral or tube feed) preterm formula. informed consent will be obtained from parents before enrollment in the study.
Exclusion Criteria
- •History of necrotizing enterocolitis, receipt of postnatal steroids, active infection, congenital malformations, chromosomal abnormality, intracranial hemorrhage more than (>) grade 2, inborn errors of metabolism, meningitis or encephalopathy, need for surgery.
Outcomes
Primary Outcomes
Growth parameter (Weight)
Time Frame: 5 days
Daily weight gain in grams and cumulative weight gain after 5 days of intervention
Growth parameter (Length)
Time Frame: 5 days
Daily length gain in cm and cumulative length gain after 5 days of intervention
Growth parameter (Head circumference)
Time Frame: 5 days
Daily head circumference gain in cm and cumulative head circumference gain after 5 days of intervention
Growth parameter (Ponderal Index)
Time Frame: 5 days
Daily changes in Ponderal Index and cumulative changes in Ponderal Index after 5 days of intervention
Growth parameter (Mid-arm circumference)
Time Frame: 5 days
Daily mid-arm circumference gain in cm and cumulative mid-arm circumference gain after 5 days of intervention
Secondary Outcomes
- Dual X-ray absorptiometry scan (DXA scan)(5 days)
- Serum adiponectin(5 days)
- Insulin-like Growth Factor 1 (IGF-1)(5 days)
- Serum Leptin(5 days)
Investigators
Nehad Nasef
Associate Professor
Mansoura University Children Hospital