Protein for Premies
This study is currently recruiting participants.
Verified January 2013 by University Hospital Tuebingen
Sponsor:
University Hospital Tuebingen
Information provided by (Responsible Party):
Axel Franz, University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT01773902
First received: January 15, 2013
Last updated: January 18, 2013
Last verified: January 2013
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Purpose
Although expressed breast milk is considered the optimal nutritional source for preterm infants, the macronutrient content is insufficient to enable optimal growth during neonatal intensive care. Optimal dose and optimal mode of administration (standardized or individualized) of enteral protein supplementation to very preterm infants have not been established.
This study aims to compare the effects on weight gain of different modes of enteral protein supplementation.
| Condition | Intervention |
|---|---|
|
Extreme Prematurity |
Dietary Supplement: High Dose Protein (Individualized) Dietary Supplement: High Dose Protein (Standardized) Dietary Supplement: Standard Protein Supplementation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | High Versus Standard Dose Protein for Very Preterm Infants |
Resource links provided by NLM:
Further study details as provided by University Hospital Tuebingen:
Primary Outcome Measures:
- Weight gain [ Time Frame: From birth - to the end of study intervention (anticipated to be on average 1 week before discharge home at approx 37 weeks PMA) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Head circumference growth [ Time Frame: From birth - to the end of study intervention (anticipated to be on average 1 week before discharge home at approx 37 weeks PMA) ] [ Designated as safety issue: No ]
Other Outcome Measures:
- Plasma amino acid profile [ Time Frame: at 2 and 4 weeks after start of intervention ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: High Dose Protein (Individualized)
Protein supplementation according to breast milk content aiming for 4.5g/kg/d of enteral protein if <1500g b.w. or 4.0g/kg/d of enteral protein if >1500g b.w. until 1 week before discharge
|
Dietary Supplement: High Dose Protein (Individualized)
Protein supplementation according to breast milk content aiming for 4.5g/kg/d of enteral protein if <1500g b.w. or 4.0g/kg/d of enteral protein if >1500g b.w. until 1 week before discharge
|
|
Experimental: High Dose Protein (Standardized)
Protein supplementation independent of individual breast milk content using a new high-dose-protein breast milk fortifier until 1 week before discharge
|
Dietary Supplement: High Dose Protein (Standardized)
Protein supplementation independent of individual breast milk content using a new high-dose-protein breast milk fortifier until 1 week before discharge
|
|
Active Comparator: Standard protein supplementation
Protein supplementation independent of individual breast milk content using a standard dose of a standard breast milk fortifier until 1 week before discharge
|
Dietary Supplement: Standard Protein Supplementation
Protein supplementation independent of individual breast milk content using a standard-dose-protein breast milk fortifier until 1 week before discharge
|
Eligibility| Ages Eligible for Study: | up to 7 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- very preterm infants <32 weeks gestation and <1500g birth weight
- > 100ml/kg/d of enteral feeding
Exclusion Criteria:
- missing informed consent
- decision not to feed breast milk
- congenital malformations
- age > 7 days at study entry
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01773902
Contacts
| Contact: Axel Franz, MD | axel.franz@med.uni-tuebingen.de |
Locations
| Germany | |
| University Children's Hospital Tuebingen | Recruiting |
| Tuebingen, Germany, 72076 | |
| Contact: Axel Franz, MD axel.franz@med.uni-tuebingen.de | |
| Principal Investigator: Christoph Maas, MD | |
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
| Principal Investigator: | Axel Franz, MD | University of Tuebingen, Germany |
More Information
No publications provided
| Responsible Party: | Axel Franz, PD Dr. med., University Hospital Tuebingen |
| ClinicalTrials.gov Identifier: | NCT01773902 History of Changes |
| Other Study ID Numbers: | PfP3.2 |
| Study First Received: | January 15, 2013 |
| Last Updated: | January 18, 2013 |
| Health Authority: | Germany: Ethics Commission |
ClinicalTrials.gov processed this record on June 17, 2013