Neonatal Cholestasis, Retinopathy of Prematurity
Conditions
Brief summary
Docosahexaenoic acid (DHA) has been shown to be particularly important for fetal and neonatal development. Infants born prematurely are at special risk for DHA insufficiency. The source of DHA after birth for preterm babies who are not fed full enterally, are mostly fat emulsions as the component of total parenteral nutrition solutions which usually do not contain DHA. The aim of this study is to investigate if the fish oil emulsion-administered from the first day of life and during parenteral nutrition-prevents infants from cholestasis and retinopathy of prematurity.
Detailed description
During the study period, preterm infants admitted to NICU were included. Infants who weighed \<1500 gr and delivered prematurely before the 32nd week of gestation were eligible for the study. Infants with major congenital anomalies, congenital infections and inborn metabolic errors were excluded from the study. Group 1: Fish-oil emulsion (20% SMOFLipid: soybean oil 60 g/dL, MCT 60 g/dL, olive oil 50 g/dL, fish oil 30 g/dL, egg phospholipids 12 g/dL, glycerol 25 g/dL, vitamin E 200 mg α-TE/L) Group 2: Soybean oil emulsion (20% Intralipid: soybean oil 200 g/dL, egg phospholipids 12 g/dL, glycerol 22,5 g/dL, vitamin E 57 mg α-TE/L).
Interventions
DIETARY_SUPPLEMENTFish-oil emulsions
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.
DIETARY_SUPPLEMENTsoybean-oil emulsion
soybean-oil emulsion
Sponsors
Dr. Sami Ulus Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 3 Days
Healthy volunteers
No
Inclusion criteria
* Infants below 32 gestational age and requiring parenteral nutrition
Exclusion criteria
* Infants with congenital anomalies, infants above 32 gestational age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Retinopathy of Prematurity | Corrected age 32 weeks or postnatal 28th day | The number of Participants with Retinopathy of Prematurity will be defined. |
Countries
Turkey (Türkiye)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 40 |
| 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 | 40 |
| Total | 80 |
Baseline characteristics
| Characteristic | Soybean-oil Emulsion | Fish-oil Emulsions | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 40 Participants | 40 Participants | 80 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous gestational age | 30 weeks STANDARD_DEVIATION 3 | 30 weeks STANDARD_DEVIATION 2 | 30 weeks STANDARD_DEVIATION 2 |
| Region of Enrollment Turkey | 40 participants | 40 participants | 80 participants |
| Sex: Female, Male Female | 18 Participants | 16 Participants | 34 Participants |
| Sex: Female, Male Male | 22 Participants | 24 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
Number of Participants With Retinopathy of Prematurity
The number of Participants with Retinopathy of Prematurity will be defined.
Time frame: Corrected age 32 weeks or postnatal 28th day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fish-oil Emulsions | Number of Participants With Retinopathy of Prematurity | 2 participants |
| Soybean-oil Emulsion | Number of Participants With Retinopathy of Prematurity | 13 participants |