Condition category
Neonatal Diseases
Date applied
07/09/2015
Date assigned
15/09/2015
Last edited
14/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Publication citations

Additional files

Editorial Notes