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

NCT03412578 | Completed

• 1 other identifier: NICU MUCH 2017
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• Growth parameter (Weight)

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

  5 days

• Growth parameter (Length)

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

  5 days

• Growth parameter (Head circumference)

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

  5 days

• 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

• Growth parameter (Ponderal Index)

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

  5 days

Secondary Outcomes (4)

• Dual X-ray absorptiometry scan (DXA scan)

  5 days

• Insulin-like Growth Factor 1 (IGF-1)

  5 days

• Serum Leptin

  5 days

• Serum adiponectin

  5 days

Study Arms (2)

Control

NO INTERVENTION

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

Massage group

ACTIVE COMPARATOR

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).

Procedure: Massage Therapy

Interventions

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).

Massage group

Eligibility Criteria

• Age: 35 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University Children Hospital: lead

Study Sites (2)

Mansoura university children hospital

Al Mansurah, El Dakahlya, 35111, Egypt

Location

Unknown Facility

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Massage

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 21, 2018
• First Posted: January 26, 2018
• Study Start: September 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: June 8, 2022

Record last verified: 2022-06

Locations

EG (2)