Feeding Patterns and Practices in Young Children With PKU During the First Two Years of Life

Nutricia Research46 enrolled

Overview

In this study the feeding patterns and practices at the introduction of a second stage phe-free protein substitute will be assessed in young children with PKU. This will be compared with the normal weaning process in healthy non-PKU age-matched children. In addition, tolerability and acceptability of the study product will be evaluated in a smaller group of subjects who have already been transferred onto a second stage protein substitute. The study is performed in 3 centers in the United Kingdom.

Part 1: For subjects with PKU, the study product will be incorporated in the diet as the second stage protein substitute until the subjects are 2 years of age. The healthy non-PKU age-matched subjects will not have the study product incorporated in their diet in order to be able to compare the weaning experience and nutritional intake of PKU subjects with non-PKU subjects. The healthy subjects will also be part of the study until the subjects are 2 years of age. Part 2: All PKU subjects will take the study product for 7 days.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

PKU

Interventions

B2970 Metabolic Texture Modified Protein SubstituteOTHER

The study product is a powdered phe-free protein substitute supplemented with long chain polyunsaturated fatty acids (LCP's), containing essential and non-essential amino acids, carbohydrate, fat, vitamins, minerals and trace elements and has been designed for use in the management of proven PKU in children aged 6 months to 5 years.

Eligibility

Sex: ALLMax age: 5 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of PKU identified on screening during the newborn period and requiring a phenylalanine free protein substitute * Subjects who are about to commence weaning and require a concentrated phe-free protein substitute to meet their total protein requirements and are aged between 4 and 10 months (Part 1) * Subjects aged under 5 years who have already been fully transferred onto a concentrated phe-free protein substitute and are willing to try the study product for 7 days (Part 2) * Written informed consent obtained from subject or parents / caregiver * May or may not have commenced weaning solids (i.e. using normal foods) Exclusion Criteria: * Presence of serious concurrent illness * Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements * Any child who has not commenced a second stage protein substitute and is over the age of 10 months * Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study * Any children having taken antibiotics over the previous 2 weeks leading up to the study

Locations (3)

Birmingham Children's Hospital

Birmingham, United Kingdom

Bradford Teaching Hospitals NHS Foundation Trust, St Luke's Hospital

Bradford, United Kingdom

JB Russell House, Gartnavel Royal Hospital

Glasgow, United Kingdom

Outcomes

Primary Outcomes

Feeding patterns- product intake

Actual intake of product and prescribed amount of product \[# sachets\] will be recorded as documented in diaries.

Time frame: up to 2 years

Feeding patterns - intake other than study product

Intakes of standard formulas / breast-milk and normal foods \[mL\] or \[g/day\] and \[frequency\] of breastfeeding, as documented in diaries.

Time frame: up to 2 years

Feeding practices and difficulties by questionnaire; position

Feeding practices entered by parents in diaries: the way the child has been fed will be assessed : categories \[sitting position e.g on lap, in chair etc\]

Time frame: up to 2 years

Feeding practices and difficulties by questionnaire; self feeding

Feeding practices entered by parents in diaries; the way the child has been fed will be assessed : \[self-feeding; parent feeding\]; \[type of self feeding: bottle, finger; spoon, fork\]

Time frame: up to 2 years

Occurence of Adverse Events [ Safety and tolerability]

Occurence of Adverse Events

Time frame: up to 2 years

Gastro-Intestinal symptoms

Occurence of GI symptoms \[yes/no\] for: * Mouth Ulcers * Tummy upset * Harder poos * Constipation * Softer poos * Vomiting * Colic * Other (free entry)

Time frame: up to 2 years

Product Acceptability yes/no

Acceptability questions \[yes/no\] for: * Refuses more than takes * Refuses as much as takes * Takes more than refuses * Spits out product * Puts spoon away * Holds in mouth but won't swallow * Closes mouth on feeding * Cries at beginning of feed * Cries at end of feed * Deliberately spills feed * Turns head away * Other (free entry)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

Weaning per group (with our without protein substitute) - descriptive

Compare the weaning , nutritional intakes \[g/day\] and metabolic control of infants taking the study product, with historical controls of the same age and weaning stage whose diet did not incorporate a semi-solid second stage protein substitute during the same time period \[parent questionnaires\]

Time frame: up to 2 years

Anxiety levels of parents - Beck's Anxiety inventory

The Beck's Anxiety Inventory, scores on domains \[0 not at all - 3 severely\]

Time frame: up to 2 years

Coping mechanisms of parents by questionnaire

Coping Health Inventory for Parents (scores on domains coping behaviour \[3 extremely helpful -0 not helpful\]

Time frame: up to 2 years

Parent experience of Feeding via questionnaire

Feeding time Parent Questionnaire, experience of parents of their child's feeding time, scores on various domains \[0-7\]

Time frame: up to 2 years