Trial Outcomes & Findings for The Influence of Fish-oil Lipid Emulsions on Neonatal Morbidities (NCT NCT01875510)

NCT ID: NCT01875510

Last Updated: 2014-07-08

Results Overview

The number of Participants with Retinopathy of Prematurity will be defined.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 80 participants
• Primary outcome timeframe: Corrected age 32 weeks or postnatal 28th day
• Results posted on: 2014-07-08

Participant Flow

Participant milestones

Measure	Fish-oil Emulsions Preterm infants will receive a fish-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and third day and after 3 gr/kg.	Soybean-oil Emulsion Preterm infants will receive a soybean-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and the third day and after 3gr/kg
Overall Study STARTED	40	40
Overall Study COMPLETED	40	40
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Influence of Fish-oil Lipid Emulsions on Neonatal Morbidities

Baseline characteristics by cohort

Measure	Fish-oil Emulsions n=40 Participants Preterm infants will receive a fish-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and third day and after 3 gr/kg.	Soybean-oil Emulsion n=40 Participants Preterm infants will receive a soybean-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and the third day and after 3gr/kg	Total n=80 Participants Total of all reporting groups
Age, Categorical <=18 years	40 Participants n=5 Participants	40 Participants n=7 Participants	80 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous gestational age	30 weeks STANDARD_DEVIATION 2 • n=5 Participants	30 weeks STANDARD_DEVIATION 3 • n=7 Participants	30 weeks STANDARD_DEVIATION 2 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	18 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	22 Participants n=7 Participants	46 Participants n=5 Participants
Region of Enrollment Turkey	40 participants n=5 Participants	40 participants n=7 Participants	80 participants n=5 Participants

PRIMARY outcome

Timeframe: Corrected age 32 weeks or postnatal 28th day

The number of Participants with Retinopathy of Prematurity will be defined.

Outcome measures

Measure	Fish-oil Emulsions n=40 Participants Preterm infants will receive a fish-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and third day and after 3 gr/kg.	Soybean-oil Emulsion n=40 Participants Preterm infants will receive a soybean-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and the third day and after 3gr/kg
Number of Participants With Retinopathy of Prematurity	2 participants	13 participants

Adverse Events

Fish-oil Emulsions

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Soybean-oil Emulsion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Serdar Beken

Dr. Sami Ulus Children's Hospital

Phone: 00903123056449

Email: serbeken@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place