Effect of Tactile/Kinaesthetic Massage Therapy on DXA Parameter of Preterm Infants

Body Composition Clinical Trial

Official title:

Effect of Tactile/Kinaesthetic Massage Therapy on Growth Parameters and Body Composition of Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03412578
• Other study ID #: NICU MUCH 2017
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: December 2018

Study information

• Verified date: June 2022
• Source: Mansoura University Children Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Body composition assessment using DXA scan was performed for total body All infants were studied on one occasion by the end of 5 days massage therapy. DXA scan was performed without sedation but a pacifier with non-metallic parts was used as needed. The scanning procedure was interrupted if movement artefacts is noted. In addition, analyses of different body regions were also performed. Regional analyses typically involved the head, each of the four extremities, and the trunk.

Blood samples were collected using standard technique at baseline and after 5 days for measurement of IGF-1, leptin and adiponectin levels using Enzyme-linked Immunosorbent Assay [ELISA kit supplied by Elabscience Biotechnology (No.1 Shizishan Street, Wuhan, Hubei, China) catalog No: E-EL-H0086].

Randomization Infants were assigned randomly, by a designated neonatologist, to treatment groups using internet based random table technique with cards in opaque sealed envelopes that were kept in the neonatal care unit. A written informed consent was obtained from the parents of each infant upon enrolment in the study. Procedures of MT, DXA scan, and laboratory analysis were performed by a designated personnel throughout the study to ensure consistency. Performers of DXA scan and laboratory measures were blinded to groups of intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Weeks to 36 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Body Composition
• Dual X-ray Absorptiometry (DXA) Scan
• Premature Birth
• Preterm Infant

Intervention

Procedure:
• Massage Therapy
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 (Field, Schanberg et al. 1986). 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 (Field, Diego et al. 2006).

Locations

Country	Name	City	State
Egypt	Mansoura university children hospital	Mansourah	El Dakahlya

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University Children Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Growth parameter (Weight)	Daily weight gain in grams and cumulative weight gain after 5 days of intervention	5 days
Primary	Growth parameter (Length)	Daily length gain in cm and cumulative length gain after 5 days of intervention	5 days
Primary	Growth parameter (Head circumference)	Daily head circumference gain in cm and cumulative head circumference gain after 5 days of intervention	5 days
Primary	Growth parameter (Mid-arm circumference)	Daily mid-arm circumference gain in cm and cumulative mid-arm circumference gain after 5 days of intervention	5 days
Primary	Growth parameter (Ponderal Index)	Daily changes in Ponderal Index and cumulative changes in Ponderal Index after 5 days of intervention	5 days
Secondary	Dual X-ray absorptiometry scan (DXA scan)	DXA scan will be performed prior to and 5 days after massage therapy to measure bone mineral density at different levels in the body	5 days
Secondary	Insulin-like Growth Factor 1 (IGF-1)	Serum level of IGF-1 will be measured at baseline and 5 days after massage therapy	5 days
Secondary	Serum Leptin	Serum level of Leptin will be measured at baseline and 5 days after massage therapy	5 days
Secondary	Serum adiponectin	Serum level of adiponectin will be measured at baseline and 5 days after massage therapy	5 days