Plain English Summary
Background and study aims
Preterm infants have significantly lower long chain polyunsaturated fatty acids (LC-PUFA) concentrations than full term infants because they miss the major period of docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) development in the brain and other organs during the third trimester of pregnancy. LC-PUFA play a potentially significant role in the modulation (control) of developmental processes affecting short- and long-term health outcomes related to growth, body composition, immune and allergic responses, and nutrition-related chronic disease. The most widely used formulation for parenteral (intravenous) nutrition (PN) is a soybean oil-based lipid emulsions (LE), which is rich in n-6 LC-PUFA and phytosterols which may cause liver toxicity and inflammation. LC-PUFAs (EPA and DHA) from fish oil may prevent the inflammatory response and even reduce any inflammation that exists. Early fish oil-based lipid emulsion (LE) administration to very low birth weight premature infants may reduce the development of chronic lung disease(CLD) and liver dysfunction by decreasing inflammatory cytokines (small signalling proteins) with IL-1β and IL-6 levels (suggesting inflammation) in serum (a component of the blood) and bronchoalveolar lavage fluid (fluid from the lungs). The aim of this study is to investigate whether this is the case.
Who can participate
Very low birth weight (VLBW) premature infants with a birth weight <1250gm or gestation age <32 weeks.
What does the study involve
Participants are randomly allocated into one of two groups. Those in group 1 are given total parenteral nutrition (TPN) containing a fish oil-based lipid emulsion. Those in group 2 are given TPN containing conventional soybean lipid emulsion. Treatment starts within 48 hours of birth and lasts for at least seven days. The dose starts at 1gm/kg but then increases by 1gm/kg per day until the maximum dose of 3gm/kg.
What are the possible benefits and risks of participating
The treatment may reduce the development of lung and liver problems by reducing inflammation.
Where is the study run from
Changhua Christian Hospital (Taiwan.)
When is study starting and how long is it expected to run
March 2012 to February 2014
Who is the main contact
Chien-Chou Hsiao
68206@cch.org.tw
Trial website
Contact information
Type
Scientific
Primary contact
Dr Chien-Chou Hsiao
ORCID ID
http://orcid.org/0000-0002-4523-5300
Contact details
135 Nanshiao Street
Changhua city
500
Taiwan
886-4-7238595 ext 1902
68206@cch.org.tw
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
101-CCH-IRP-15
Study information
Scientific title
Fish oil-based lipid emulsion attenuates inflammatory cytokines and development of bronchopulmonary dysplasia in extremely premature infants: a randomised controlled trial
Acronym
Study hypothesis
The aim of this study to is investigate whether giving preterm infants an early supply of long chain polyunsaturated fatty acids (LC-PUFA) and fish oil-based lipid emulsions (LE) containing ω-3 LC-PUFAs helps prevent the development of bronchopulmonary dysplasia (BPD) by modulating inflammation and neonatal immune function.
Ethics approval
Changhua Christian Hospital Institutional Review Board Committee A, 22/12/2011, ref: CCH-IRB-110909
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Insufficent docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) in premature babies.
Intervention
Sixty very low birth weight (VLBW) premature infants were randomized to 2 groups:
1. Study group received total parenteral nutrition (TPN) containing fish oil-based lipid emulsion (SMOF lipid contain 30% soybean-LCT, 30% MCT, 25% olive oil and 15% fish oil).
2.Control group received TPN containing conventional soybean lipid emulsion (Lipovenoes MCT 20%).
Treatment was started within 48 hours of birth and then for at least the next 7 days. The dose of both lipid emulsions were 1 gm/kg at first day of TPN, increasing to 1 gm/kg per day until 3 gm/kg. Macronutrients were provided using the same products for glucose and amino acid solutions in both groups. The premature infant was fed by NG tube or bottle with breast milk or premature formula milk if breast milk was not enough.
Intervention type
Supplement
Phase
Drug names
Primary outcome measures
Comparison of immune effects of Interleukin (IL)-1β and IL-6, assessed on the first 48 hours and 7 days after TPN use, including serum IL-1β and IL-6 and bronchoalveolar lavage fluid from tracheal aspiration if intubated infants. The levels of cytokines in the serum and bronchoalveolar lavage fluid were estimated by enzyme-linked immunosorbent assay.
Secondary outcome measures
1. Mortality
2. Ventilator use days
3. Oxygen dependent days
4. Length of hospital stay (LOS)
5. Growth rate
6. Liver function
7. Parenteral nutrition associated cholestasis (PNAC)
8. Bronchopulmonary dysplasia (BPD)
9. Retinopathy of prematurity(ROP)
10. Necrotizing enterocolitis (NEC)
11. Intraventricular hemorrhage (IVH)
12. Nosocomial infection
Follow up program will finish when the infant is discharged.
Overall trial start date
01/03/2012
Overall trial end date
28/02/2014
Reason abandoned
Eligibility
Participant inclusion criteria
PVLBW infants who weighed below 1250 gm and gestational age below 32 weeks
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Chromosomal disorders or lethal congenital abnormalities
2. Congenital cyanotic heart disease
3. Anatomic obstructive gastrointestinal pathologies, such as intestinal malrotation with or without volvulus, stenosis, or atresia, gastroschisis, omphalocele and Hirschsprung’s disease
4. Confirmed or family history of hereditary metabolic disorder
Recruitment start date
01/03/2012
Recruitment end date
25/02/2014
Locations
Countries of recruitment
Taiwan
Trial participating centre
Changhua Christian Hospital
500
Taiwan
Sponsor information
Organisation
Changhua Christian Hospital
Sponsor details
135 Nanshaio Street
Changhua city
500
Taiwan
886-4-7238595
68206@cc.org.tw
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Changhua Christian Hospital (Taiwan)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
November 2015. Will submit to BMJ
Intention to publish date
30/11/2015
Participant level data
Available on request
Results - basic reporting
Publication summary