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Fish oil-based lipid emulsion decrease inflammation and bronchopulmonary dysplasia in extremely premature infants

Fish oil-based lipid emulsion attenuates inflammatory cytokines and development of bronchopulmonary dysplasia in extremely premature infants: a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11427103
Enrollment
60
Registered
2015-09-15
Start date
2012-03-01
Completion date
Unknown
Last updated
2018-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insufficent docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) in premature babies Neonatal Diseases

Interventions

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 contai

Sponsors

Changhua Christian Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: PVLBW infants who weighed below 1250 gm and gestational age below 32 weeks

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Comparison of immune effects of Interleukin (IL)-1ß and IL-6, assessed on the first 48 hours and 7 days after TPN use, including serum IL-1ß 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

MeasureTime frame
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.

Countries

Taiwan

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026