Effect of Tactile/Kinaesthetic Massage Therapy on DXA Parameter of Preterm Infants
Condition: Preterm Infant; Body Composition; Dual X-ray Absorptiometry (DXA) Scan
MeSH terms: Premature Birth
Study type: Interventional

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.

      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.
    

Intervention name(s): Massage Therapy
Intervention type(s): Procedure
Intervention description(s): 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).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other