Trial Outcomes & Findings for Early Supplementation of Enteral Microlipid With and Without Fish Oil in Premature Infants With Enterostomies (NCT NCT01674478)

Results Overview

Compare the serum biomarkers of inflammatory cytokines of the infants receiving ML/FO to the infants only receiving ML between the initial feeding after placement of an ostomy and reanastomosis

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

18 participants

Primary outcome timeframe

2 years and 5 months

Results posted on

2018-12-04

Participant Flow

Participant milestones

Participant milestones
Measure	Microlipid and Fish Oil Group This group will be given early enteral lipid supplementation with Microlipid and fish oil. Microlipid and fish oil: Fish oil will start with initial feeding after ostomy placement and Microlipid will start once infant tolerating enteral feeds at 20 ml /kg/d while weaning the Intralipid, which both will be continued until reanastomosis.	Microlipid Group This group will be given early enteral lipid supplementation only with Microlipid. Microlipid: A small amount (ml) of Microlipid to match the amount of fish oil in ML/FO group will start with initial feeding after ostomy placement and Microlipid will start once infant tolerating enteral feeds at 20 ml /kg/d while weaning the Intralipid, which will be continued until reanastomosis.
Overall Study STARTED	9	9
Overall Study COMPLETED	9	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Early Supplementation of Enteral Microlipid With and Without Fish Oil in Premature Infants With Enterostomies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Microlipid and Fish Oil Group n=9 Participants This group will be given early enteral lipid supplementation with Microlipid and fish oil. Microlipid and fish oil: Fish oil will start with initial feeding after ostomy placement and Microlipid will start once infant tolerating enteral feeds at 20 ml /kg/d while weaning the Intralipid, which both will be continued until reanastomosis.	Microlipid Group n=9 Participants This group will be given early enteral lipid supplementation only with Microlipid. Microlipid: A small amount (ml) of Microlipid to match the amount of fish oil in ML/FO group will start with initial feeding after ostomy placement and Microlipid will start once infant tolerating enteral feeds at 20 ml /kg/d while weaning the Intralipid, which will be continued until reanastomosis.	Total n=18 Participants Total of all reporting groups
Age, Continuous	26.3 weeks STANDARD_DEVIATION 2.0 • n=5 Participants	25.9 weeks STANDARD_DEVIATION 2.0 • n=7 Participants	26.1 weeks STANDARD_DEVIATION 2.0 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years and 5 months

Population: No data collected

Compare the serum biomarkers of inflammatory cytokines of the infants receiving ML/FO to the infants only receiving ML between the initial feeding after placement of an ostomy and reanastomosis

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 2 years and 5 months

Population: No data collected

Compare the serum biomarkers of oxidative stress of the infants receiving ML/FO to the infants only receiving ML between the initial feeding after placement of an ostomy and reanastomosis

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years and 5 months

To compare the average enteral calorie (total calorie) intake of infants receiving ML/FO to the group only receiving ML between the initial feeding after placement of an ostomy and reanastomosis

Outcome measures

Outcome measures
Measure	Microlipid and Fish Oil Group n=9 Participants This group will be given early enteral lipid supplementation with Microlipid and fish oil. Microlipid and fish oil: Fish oil will start with initial feeding after ostomy placement and Microlipid will start once infant tolerating enteral feeds at 20 ml /kg/d while weaning the Intralipid, which both will be continued until reanastomosis.	Microlipid Group n=9 Participants This group will be given early enteral lipid supplementation only with Microlipid. Microlipid: A small amount (ml) of Microlipid to match the amount of fish oil in ML/FO group will start with initial feeding after ostomy placement and Microlipid will start once infant tolerating enteral feeds at 20 ml /kg/d while weaning the Intralipid, which will be continued until reanastomosis.
The Average Enteral Calorie (Total Calorie) Intake Before Reanast	52.1 kcal/kg/day Standard Deviation 23.6	56.7 kcal/kg/day Standard Deviation 15.6

SECONDARY outcome

Timeframe: 2 years and 5 months

To compare the the average weight gain (g/day) of infants receiving ML/FO to the infants only receiving ML after reanastomosis

Outcome measures

Outcome measures
Measure	Microlipid and Fish Oil Group n=9 Participants This group will be given early enteral lipid supplementation with Microlipid and fish oil. Microlipid and fish oil: Fish oil will start with initial feeding after ostomy placement and Microlipid will start once infant tolerating enteral feeds at 20 ml /kg/d while weaning the Intralipid, which both will be continued until reanastomosis.	Microlipid Group n=8 Participants This group will be given early enteral lipid supplementation only with Microlipid. Microlipid: A small amount (ml) of Microlipid to match the amount of fish oil in ML/FO group will start with initial feeding after ostomy placement and Microlipid will start once infant tolerating enteral feeds at 20 ml /kg/d while weaning the Intralipid, which will be continued until reanastomosis.
The Average Weight Gain (g/Day) After Reanastomosis	26.6 g/d Standard Deviation 8.5	20.9 g/d Standard Deviation 12.2

Adverse Events

Microlipid and Fish Oil Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Microlipid Group

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. Qing Yang

Wake Forest University Health Sciences

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place