Feeding Patterns and Practices in Young Children With PKU During the First Two Years of Life
- Conditions
- PKU
- Interventions
- Other: B2970 Metabolic Texture Modified Protein Substitute
- Registration Number
- NCT03913156
- Lead Sponsor
- Nutricia Research
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Part 2 B2970 Metabolic Texture Modified Protein Substitute Part 2 of the study will recruit subjects who have already been introduced to a concentrated phe-free protein substitute (i.e. have already transferred from phe-free infant formula onto a second stage protein substitute). This group will be included to evaluate the acceptability of the study product in patients who have already moved onto a second stage protein substitute. Part 1 B2970 Metabolic Texture Modified Protein Substitute Part 1 of the study will recruit subjects who are about to be introduced to a concentrated phe-free protein substitute (i.e. second stage protein substitute) for the first time.
- Primary Outcome Measures
Name Time Method Intake of energy and nutritients: Study product up to 2 years Intakes of energy and nutrients from the study product \[diet diary; #g product/day\]
Feeding patterns- product intake up to 2 years Actual intake of product and prescribed amount of product \[# sachets\] will be recorded as documented in diaries.
Feeding patterns - intake other than study product up to 2 years Intakes of standard formulas / breast-milk and normal foods \[mL\] or \[g/day\] and \[frequency\] of breastfeeding, as documented in diaries.
Feeding practices and difficulties by questionnaire; position up to 2 years Feeding practices entered by parents in diaries: the way the child has been fed will be assessed : categories \[sitting position e.g on lap, in chair etc\]
Feeding practices and difficulties by questionnaire; self feeding up to 2 years Feeding practices entered by parents in diaries; the way the child has been fed will be assessed : \[self-feeding; parent feeding\]; \[type of self feeding: bottle, finger; spoon, fork\]
Occurence of Adverse Events [ Safety and tolerability] up to 2 years Occurence of Adverse Events
Gastro-Intestinal symptoms up to 2 years Occurence of GI symptoms \[yes/no\] for:
* Mouth Ulcers
* Tummy upset
* Harder poos
* Constipation
* Softer poos
* Vomiting
* Colic
* Other (free entry)Product Acceptability yes/no up to 2 years 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)Blood Phenylalanine control: Phe levels up to 2 years Phe levels \[umol/L\]
Blood Tyrosine levels up to 2 years Tyrosine levels \[umol/L\]
Intake of energy and nutritients: Weaning up to 2 years Intakes of energy and nutrients from the weaning diet: descriptive information, intakes \[# meals or snacks/day\]
Anthropometry: weight up to 2 years Weight \[g\]
Anthropometry: length up to 2 years Length \[cm\]
- Secondary Outcome Measures
Name Time Method Weaning per group (with our without protein substitute) - descriptive up to 2 years 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 \[parent questionnaires\]
Anxiety levels of parents - Beck's Anxiety inventory up to 2 years The Beck's Anxiety Inventory, scores on domains \[0 not at all - 3 severely\]
Coping mechanisms of parents by questionnaire up to 2 years Coping Health Inventory for Parents (scores on domains coping behaviour \[3 extremely helpful -0 not helpful\]
Parent experience of Feeding via questionnaire up to 2 years Feeding time Parent Questionnaire, experience of parents of their child's feeding time, scores on various domains \[0-7\]
Trial Locations
- 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