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Completed

NCT Number: NCT04281563

Medium-chain Triglyceride Oil Massage on Growth in Preterm

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.

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Key information

Conditions

Preterm Infants Growth MCT Oil Massage

Age range

28 week–37 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ditmanson Medical Foundation Chia-Yi Christian Hospital

Chiayi City, 60002, Taiwan

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

massage with MCT oil (group 1)

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.

Other names: massage without MCT oil (group 2)

Primary outcomes

  1. weight

    Time frame: on study days 1 to 7

    weight increase

Secondary outcomes

  1. height and head circumference

    Time frame: on study days 1 to 7

    height and head circumference increase

Sponsors and collaborators

Lead sponsor

Chiayi Christian Hospital

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 24, 2020
Registry last updated
Feb 24, 2020

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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