Medium-chain Triglyceride Oil Massage on Growth in Preterm

NCT ID: NCT04281563

Last Updated: 2020-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-07

Study Completion Date

2019-07-06

Brief Summary

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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.

Detailed Description

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Conditions

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Preterm Infants MCT Oil Massage Growth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators
Data were analyzed by a researcher who was not informed of the intervention group assignment.

Study Groups

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the MCT oil massage

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.

Group Type EXPERIMENTAL

massage with MCT oil (group 1)

Intervention Type OTHER

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.

massage alone

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.

Group Type PLACEBO_COMPARATOR

massage with MCT oil (group 1)

Intervention Type OTHER

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.

no massage groups

no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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massage with MCT oil (group 1)

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.

Intervention Type OTHER

Other Intervention Names

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massage without MCT oil (group 2)

Eligibility Criteria

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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.
Minimum Eligible Age

28 Weeks

Maximum Eligible Age

37 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chiayi Christian Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ditmanson Medical Foundation Chia-Yi Christian Hospital

Chiayi City, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type DERIVED
PMID: 34397733 (View on PubMed)

Other Identifiers

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106041

Identifier Type: -

Identifier Source: org_study_id

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