Medium-chain Triglyceride Oil Massage on Growth in Preterm

Growth Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04281563
• Other study ID #: 106041
• Status: Completed
• Phase: N/A
• Start date: July 7, 2017
• Est. completion date: July 6, 2019

Study information

• Verified date: February 2020
• Source: Chiayi Christian Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 6, 2019
• Est. primary completion date: July 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Weeks to 37 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Growth
• MCT Oil Massage
• Premature Birth
• Preterm Infants

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Taiwan	Ditmanson Medical Foundation Chia-Yi Christian Hospital	Chiayi City

Sponsors (1)

Lead Sponsor	Collaborator
Chiayi Christian Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight	weight increase	on study days 1 to 7
Secondary	height and head circumference	height and head circumference increase	on study days 1 to 7