Trial Outcomes & Findings for Clinical Experience With Numeta in Preterm Infants (NCT NCT01981057)

Results Overview

Prescriptions for protein in parenteral nutrition solutions will be ordered individually and flipped with Numeta or "vice versa". This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations.

Recruitment status

COMPLETED

Target enrollment

50 participants

Primary outcome timeframe

6 weeks

Results posted on

2017-10-26

Participant Flow

Participant milestones

Participant milestones
Measure	Numeta parenteral receipt prescribed with Numeta Numeta: parenteral receipt prescribed with Numeta Individual: parenteral receipt prescribed individually	Individual individually prescribed parenteral receipt Numeta: parenteral receipt prescribed with Numeta Individual: parenteral receipt prescribed individually
Overall Study STARTED	50	50
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Experience With Numeta in Preterm Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Numeta n=50 Participants parenteral receipt prescribed with Numeta Numeta: parenteral receipt prescribed with Numeta Individual: parenteral receipt prescribed individually	Individual n=50 Participants individually prescribed parenteral receipt Numeta: parenteral receipt prescribed with Numeta Individual: parenteral receipt prescribed individually	Total n=100 Participants Total of all reporting groups
Region of Enrollment Austria	50 participants n=5 Participants	50 participants n=7 Participants	100 participants n=5 Participants
Age, Continuous	233 days of gestation n=5 Participants	233 days of gestation n=7 Participants	233 days of gestation n=5 Participants
Age, Categorical <=18 years	50 Participants n=5 Participants	50 Participants n=7 Participants	100 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
Sex: Female, Male Female	21 Participants n=5 Participants	21 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	29 Participants n=7 Participants	58 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Prescriptions for protein in parenteral nutrition solutions will be ordered individually and flipped with Numeta or "vice versa". This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations.

Outcome measures

Outcome measures
Measure	Numeta n=50 Participants parenteral receipt prescribed with Numeta Numeta: parenteral receipt prescribed with Numeta Individual: parenteral receipt prescribed individually	Individual n=50 Participants individually prescribed parenteral receipt Numeta: parenteral receipt prescribed with Numeta Individual: parenteral receipt prescribed individually
Protein	3.1 g/kg/d Interval 1.6 to 4.1	3.6 g/kg/d Interval 1.7 to 5.0

SECONDARY outcome

Timeframe: 6 weeks

Prescriptions for energy in parenteral nutrition solutions will be ordered individually and flipped with Numeta or "vice versa". This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Prescriptions for carbohydrates in parenteral nutrition solutions will be ordered individually and flipped with Numeta or "vice versa". This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Prescriptions for fat in parenteral nutrition solutions will be ordered individually and flipped with Numeta or "vice versa". This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Prescriptions for sodium in parenteral nutrition solutions will be ordered individually and flipped with Numeta or "vice versa". This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Prescriptions for Potassium in parenteral nutrition solutions will be ordered individually and flipped with Numeta or "vice versa". This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Prescriptions for calcium in parenteral nutrition solutions will be ordered individually and flipped with Numeta or "vice versa". This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Prescriptions for magnesium in parenteral nutrition solutions will be ordered individually and flipped with Numeta or "vice versa". This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Prescriptions for phosphorous in parenteral nutrition solutions will be ordered individually and flipped with Numeta or "vice versa". This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Osmolarity in parenteral nutrition solutions will be calculated individually and flipped with Numeta or "vice versa". This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations

Outcome measures

Outcome data not reported

Adverse Events

Numeta

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Individual

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

Nadja Haiden M.D.

Medical University of Vienna

Phone: +4314040032320

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place