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Comparison of two breast-feeding techniques in newborns with Phenylketonuria

Breast-feeding techniques PKU - Breast-feeding techniques PKU

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON58068
Enrollment
25
Registered
2025-03-20
Start date
2025-09-01
Completion date
Unknown
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

phenylketonuria, PKU, Phenylalanine hydroxylase deficiency , PAH-deficiency phenylketonuria

Interventions

BreastfeedingTechnique 1: a measured volume of a Phe- free infant formula is given before each breast feed to partially satisfy the infant. This is the same for each feed throughout the day. The exact
blood Phe concentrations. This technique is commonly used in the UK for over 40 years and is also used in one of the participating centers of the Netherlands.&nbsp
Technique 2: breastfeeding is given alternately with the Phe-free infant formula. For example, the infant drinks from the breast at 07:00 in the morning and will have a bottle of phenylalanine-free in

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: A positive new-born screening for PKU, confirmed by the metabolic laboratory of the participating center. 

Exclusion criteria

Exclusion criteria: Premature newborns as pre-term human milk differs from a term human milk. Infants with the differential diagnosis BH4 deficiencyInfants of mothers with PKUInfants treated with sapropterin 

Design outcomes

Primary

MeasureTime frame
Number and percentage of blood Phe levels within target levels (120-360µmol/l). Growth data. Weight/age and length/age will be expressed in Z-scores. 

Secondary

MeasureTime frame
Comparison of the composition of breastmilk between the two breast-feeding techniques (pre-measured technique vs. alternating technique) at different stages of lactation. Amino acid content (including Phe) and fat content will be reported. 

Countries

Netherlands, United Kingdom

Contacts

Public ContactAMJ Wegberg

Universitair Medisch Centrum Groningen

a.m.j.van.wegberg@umcg.nl0627158230

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 11, 2026