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Completed

NCT Number: NCT03412578

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

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.

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Key information

Age range

35 week–36 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura university children hospital, Al Mansurah, El Dakahlya, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Massage therapy

Procedure

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).

Primary outcomes

  1. Growth parameter (Weight)

    Time frame: 5 days

    Daily weight gain in grams and cumulative weight gain after 5 days of intervention

  2. Growth parameter (Length)

    Time frame: 5 days

    Daily length gain in cm and cumulative length gain after 5 days of intervention

  3. Growth parameter (Head circumference)

    Time frame: 5 days

    Daily head circumference gain in cm and cumulative head circumference gain after 5 days of intervention

  4. 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

  5. Growth parameter (Ponderal Index)

    Time frame: 5 days

    Daily changes in Ponderal Index and cumulative changes in Ponderal Index after 5 days of intervention

Secondary outcomes

  1. Dual X-ray absorptiometry scan (DXA scan)

    Time frame: 5 days

    DXA scan will be performed prior to and 5 days after massage therapy to measure bone mineral density at different levels in the body

  2. Insulin-like Growth Factor 1 (IGF-1)

    Time frame: 5 days

    Serum level of IGF-1 will be measured at baseline and 5 days after massage therapy

  3. Serum Leptin

    Time frame: 5 days

    Serum level of Leptin will be measured at baseline and 5 days after massage therapy

  4. Serum adiponectin

    Time frame: 5 days

    Serum level of adiponectin will be measured at baseline and 5 days after massage therapy

Sponsors and collaborators

Lead sponsor

Mansoura University Children Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jan 26, 2018
Registry last updated
Jun 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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