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

Primary Purpose

Preterm Infant, Body Composition, Dual X-ray Absorptiometry (DXA) Scan

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Massage Therapy
Sponsored by
Mansoura University Children Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Preterm Infant

Eligibility Criteria

35 Weeks - 36 Weeks (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mansoura university children hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control

Massage group

Arm Description

Infants in this group will receive ordinary supportive care and will not receive Massage Therapy

Infants in this group will receive 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). During massage therapy, infant's behavioural reaction was observed for signs of distress (e.g., yawning, finger splaying, crying).

Outcomes

Primary Outcome Measures

Growth parameter (Weight)
Daily weight gain in grams and cumulative weight gain after 5 days of intervention
Growth parameter (Length)
Daily length gain in cm and cumulative length gain after 5 days of intervention
Growth parameter (Head circumference)
Daily head circumference gain in cm and cumulative head circumference gain after 5 days of intervention
Growth parameter (Mid-arm circumference)
Daily mid-arm circumference gain in cm and cumulative mid-arm circumference gain after 5 days of intervention
Growth parameter (Ponderal Index)
Daily changes in Ponderal Index and cumulative changes in Ponderal Index after 5 days of intervention

Secondary Outcome Measures

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
Insulin-like Growth Factor 1 (IGF-1)
Serum level of IGF-1 will be measured at baseline and 5 days after massage therapy
Serum Leptin
Serum level of Leptin will be measured at baseline and 5 days after massage therapy
Serum adiponectin
Serum level of adiponectin will be measured at baseline and 5 days after massage therapy

Full Information

First Posted
January 21, 2018
Last Updated
June 7, 2022
Sponsor
Mansoura University Children Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03412578
Brief Title
Effect of Tactile/Kinaesthetic Massage Therapy on DXA Parameter of Preterm Infants
Official Title
Effect of Tactile/Kinaesthetic Massage Therapy on Growth Parameters and Body Composition of Preterm Infants
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University Children Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infant, Body Composition, Dual X-ray Absorptiometry (DXA) Scan

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Infants in this group will receive ordinary supportive care and will not receive Massage Therapy
Arm Title
Massage group
Arm Type
Active Comparator
Arm Description
Infants in this group will receive 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). During massage therapy, infant's behavioural reaction was observed for signs of distress (e.g., yawning, finger splaying, crying).
Intervention Type
Procedure
Intervention Name(s)
Massage Therapy
Intervention Description
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 Outcome Measure Information:
Title
Growth parameter (Weight)
Description
Daily weight gain in grams and cumulative weight gain after 5 days of intervention
Time Frame
5 days
Title
Growth parameter (Length)
Description
Daily length gain in cm and cumulative length gain after 5 days of intervention
Time Frame
5 days
Title
Growth parameter (Head circumference)
Description
Daily head circumference gain in cm and cumulative head circumference gain after 5 days of intervention
Time Frame
5 days
Title
Growth parameter (Mid-arm circumference)
Description
Daily mid-arm circumference gain in cm and cumulative mid-arm circumference gain after 5 days of intervention
Time Frame
5 days
Title
Growth parameter (Ponderal Index)
Description
Daily changes in Ponderal Index and cumulative changes in Ponderal Index after 5 days of intervention
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Dual X-ray absorptiometry scan (DXA scan)
Description
DXA scan will be performed prior to and 5 days after massage therapy to measure bone mineral density at different levels in the body
Time Frame
5 days
Title
Insulin-like Growth Factor 1 (IGF-1)
Description
Serum level of IGF-1 will be measured at baseline and 5 days after massage therapy
Time Frame
5 days
Title
Serum Leptin
Description
Serum level of Leptin will be measured at baseline and 5 days after massage therapy
Time Frame
5 days
Title
Serum adiponectin
Description
Serum level of adiponectin will be measured at baseline and 5 days after massage therapy
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Weeks
Maximum Age & Unit of Time
36 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Mansoura university children hospital
City
Mansourah
State/Province
El Dakahlya
ZIP/Postal Code
35111
Country
Egypt
City
Mansourah
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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