Protein for Premies

Conditions

Extreme Prematurity

Brief summary

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.

Mathes M, Maas C, Bleeker C, Vek J, Bernhard W, Peter A, Poets CF, Franz AR.

2018-05-0821 citations

10.1186/s12887-018-1136-5

Effect of Increased Enteral Protein Intake on Growth in Human Milk–Fed Preterm Infants

Christoph Maas, Michaela Mathes, Christine Bleeker, Julia Vek, Wolfgang Bernhard et al. (9 authors)

JAMA Pediatrics2016-11-2861 citations

10.1001/jamapediatrics.2016.2681

Choline and polyunsaturated fatty acids in preterm infants' maternal milk.

Maas C, Franz AR, Shunova A, Mathes M, Bleeker C, Poets CF, Schleicher E, Bernhard W.

2016-05-1042 citations

10.1007/s00394-016-1220-2

Interventions

DIETARY_SUPPLEMENTHigh 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_SUPPLEMENTHigh 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_SUPPLEMENTStandard Protein Supplementation

Protein supplementation independent of individual breast milk content using a standard-dose-protein breast milk fortifier until 1 week before discharge

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

No minimum to 7 Days

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame
Weight gain	From birth - to the end of study intervention (anticipated to be on average 1 week before discharge home at approx 37 weeks PMA)

Secondary

Measure	Time frame
Head circumference growth	From birth - to the end of study intervention (anticipated to be on average 1 week before discharge home at approx 37 weeks PMA)

Other

Measure	Time frame
Plasma amino acid profile	at 2 and 4 weeks after start of intervention

Countries

Germany

Outcome results

None listed