Preterm InfantsNCT04281563
Medium-chain Triglyceride Oil Massage on Growth in Preterm
A study testing massage with MCT oil (group 1) in people with Preterm Infants and MCT Oil Massage, run by Chiayi Christian Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 28 to 37 weeks
- Conditions the study is for
- Preterm Infants, MCT Oil Massage, Growth
- What is being tested?
- massage with MCT oil (group 1)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Jul 2017to 6 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 to 37 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- gestational age between 28 and 37 weeks;
- weight between 1500 and 2000 g after enrollment;
- medically stable condition;
- ≥120 cc per day feeding.
Who cannot join
- congenital anomalies;
- skin disease;
- requirement for mechanical ventilation;
- requirement for O2 therapy;
- presence of fracture.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Ditmanson Medical Foundation Chia-Yi Christian Hospital
Chiayi City, 60002
About this study
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
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.
- Conditions
- Preterm Infants, MCT Oil Massage, Growth
- Being tested
- massage with MCT oil (group 1)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
massage with MCT oil (group 1)Other
Also called massage without MCT oil (group 2)
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.
| Study group | Role | What they receive |
|---|---|---|
| the MCT oil massage | Experimental | 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. Receives: Other: massage with MCT oil (group 1) |
| massage alone | Placebo comparator | 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. Receives: Other: massage with MCT oil (group 1) |
| no massage groups | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight
weight increase
Measured: on study days 1 to 7
Secondary outcomes (1)
height and head circumference
height and head circumference increase
Measured: on study days 1 to 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start7 Jul 2017
- Primary completion6 Jul 2019
- Study completion6 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm InfantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiayi Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04281563
- Sponsor's protocol ID
- 106041
- Status last verified
- Feb 2020
- First submitted
- 19 Feb 2020
- Last updated
- 24 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34397733
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04281563
- Acronym / sponsor ID
- 106041
- Conditions
- Preterm Infants, MCT Oil Massage, Growth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Chiayi Christian HospitalUniversity, hospital or other
- Study start
- 7 Jul 2017 (actual)
- Primary completion
- 6 Jul 2019 (actual)
- Study completion
- 6 Jul 2019 (actual)
- First posted
- 24 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| the MCT oil massage | Experimental | Other: massage with MCT oil (group 1)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. |
| massage alone | Placebo comparator | Other: massage with MCT oil (group 1)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 massage groups | No intervention | –no intervention |
Who may qualify
- Ages
- 28 to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- gestational age between 28 and 37 weeks;
- weight between 1500 and 2000 g after enrollment;
- medically stable condition;
- ≥120 cc per day feeding.
Key exclusion criteria (5 listed)
- congenital anomalies;
- skin disease;
- requirement for mechanical ventilation;
- requirement for O2 therapy;
- presence of fracture.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| massage with MCT oil (group 1)Also: massage without MCT oil (group 2)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 | massage alone, the MCT oil massage |
Primary outcome
weight
Time frame: on study days 1 to 7
weight increase
1 secondary outcome
height and head circumference
Time frame: on study days 1 to 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Derived from this study: PubMed 34397733Liao 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.
- Individual participant dataSharing planned: No
Related trials for Preterm Infants
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing massage with MCT oil (group 1) in people with Preterm Infants and MCT Oil Massage, run by Chiayi Christian Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight (time frame: on study days 1 to 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04281563, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2020.