search
Back to results

Medium-chain Triglyceride Oil Massage on Growth in Preterm

Primary Purpose

Preterm Infants, MCT Oil Massage, Growth

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
massage with MCT oil (group 1)
Sponsored by
Chiayi Christian Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Preterm Infants

Eligibility Criteria

28 Weeks - 37 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. gestational age between 28 and 37 weeks;
  2. weight between 1500 and 2000 g after enrollment;
  3. medically stable condition;
  4. ≥120 cc per day feeding.

Exclusion Criteria:

  1. congenital anomalies;
  2. skin disease;
  3. requirement for mechanical ventilation;
  4. requirement for O2 therapy;
  5. presence of fracture.

Sites / Locations

  • Ditmanson Medical Foundation Chia-Yi Christian Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

the MCT oil massage

massage alone

no massage groups

Arm Description

The neonates received massage with MCT oil. The 10-min massage intervention consisted of two 5-min phases: tactile and kinesthetic stimulation, which were given three times a day for 7 consecutive days.

The neonates received massage without MCT oil. The 10-min massage intervention consisted of two 5-min phases: tactile and kinesthetic stimulation, which were given three times a day for 7 consecutive days.

no intervention

Outcomes

Primary Outcome Measures

weight
weight increase

Secondary Outcome Measures

height and head circumference
height and head circumference increase

Full Information

First Posted
February 19, 2020
Last Updated
February 20, 2020
Sponsor
Chiayi Christian Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04281563
Brief Title
Medium-chain Triglyceride Oil Massage on Growth in Preterm
Official Title
The Effect of Medium-chain Triglyceride Oil Massage on Physical Growth in Preterm Infants Weighing Between 1500 and 2000 g: a Prospective Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
July 7, 2017 (Actual)
Primary Completion Date
July 6, 2019 (Actual)
Study Completion Date
July 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chiayi Christian Hospital

4. Oversight

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

5. Study Description

Brief Summary
Aim: To explore the effect of medium-chain triglyceride (MCT) oil massage on growth in preterm infants. Methods: This randomized controlled trial was conducted in the newborn center of a regional hospital in Taiwan. Preterm infants weighing between 1500 and 2000 g were recruited and randomly assigned to three groups: the MCT oil massage, massage alone and no massage groups. The massages were given three times per day for 7 consecutive days. Weight, length and head circumference were measured in the three groups at birth and on study days 1 to 7.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infants, MCT Oil Massage, Growth

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
Data were analyzed by a researcher who was not informed of the intervention group assignment.
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
the MCT oil massage
Arm Type
Experimental
Arm Description
The neonates received massage with MCT oil. The 10-min massage intervention consisted of two 5-min phases: tactile and kinesthetic stimulation, which were given three times a day for 7 consecutive days.
Arm Title
massage alone
Arm Type
Placebo Comparator
Arm Description
The neonates received massage without MCT oil. The 10-min massage intervention consisted of two 5-min phases: tactile and kinesthetic stimulation, which were given three times a day for 7 consecutive days.
Arm Title
no massage groups
Arm Type
No Intervention
Arm Description
no intervention
Intervention Type
Other
Intervention Name(s)
massage with MCT oil (group 1)
Other Intervention Name(s)
massage without MCT oil (group 2)
Intervention Description
Two trained nurse took turns performing standardized massage techniques in group 1 and group 2. The difference was that in group 1, the neonates received massage with MCT oil, and in group 2, the neonates received massage without using the oil. The 10-min massage intervention consisted of two 5-min phases: tactile and kinesthetic stimulation (13), which were given three times a day for 7 consecutive days. The massage force was approximately 300 grams, and the massager practiced applying the pressure by using a food scale. The massage was given in the prone and supine positions, and the actions included gentle touching of the head, back and limbs for five 1-min periods, followed by six passive flexion/extension movements lasting 10 s apiece for each arm, then each leg, and finally both legs together for a total of five 1-min periods. Premature infants in the oil massage group received massage with 10 mL/kg/day of MCT oil divided equally into three applications.
Primary Outcome Measure Information:
Title
weight
Description
weight increase
Time Frame
on study days 1 to 7
Secondary Outcome Measure Information:
Title
height and head circumference
Description
height and head circumference increase
Time Frame
on study days 1 to 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
28 Weeks
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: gestational age between 28 and 37 weeks; weight between 1500 and 2000 g after enrollment; medically stable condition; ≥120 cc per day feeding. Exclusion Criteria: congenital anomalies; skin disease; requirement for mechanical ventilation; requirement for O2 therapy; presence of fracture.
Facility Information:
Facility Name
Ditmanson Medical Foundation Chia-Yi Christian Hospital
City
Chiayi City
ZIP/Postal Code
60002
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34397733
Citation
Liao YC, Wan YH, Chen PH, Hsieh LY. Efficacy of medium-chain triglyceride oil massage on growth in preterm infants: a randomized controlled trial: A CONSORT-compliant article. Medicine (Baltimore). 2021 Jul 30;100(30):e26794. doi: 10.1097/MD.0000000000026794.
Results Reference
derived

Learn more about this trial

Medium-chain Triglyceride Oil Massage on Growth in Preterm

We'll reach out to this number within 24 hrs