Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619000616178
Ethics application status
Approved
Date submitted
13/04/2019
Date registered
24/04/2019
Date last updated
24/04/2019
Date data sharing statement initially provided
24/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Curds in the Way: Establishing Normal Ultrasound Appearances of the Contents of Newborn Bowel when Babies are Fed Fortified Breastmilk.
Scientific title
Curds in the Way: Establishing Normal Sonographic Appearances of Neonatal Bowel on Fortified Breastmilk Feeds
Secondary ID [1] 297976 0
None
Universal Trial Number (UTN)
U1111-1231-7481
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Milk Curd Obstruction 312385 0
Condition category
Condition code
Oral and Gastrointestinal 310940 310940 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
2 abdominal ultrasounds in each of 20 neonates in the Auckland City Hospital Neonatal Intensive Care ward. The first will be when on regular breastmilk feeds but before the addition of fortifier. The second will be 10-14 days after initiation of regular fortified breastmilk feeds.
These babies will have no known gastrointestinal pathology as the aim is to establish normal sonographic appearances of bowel contents before and after fortified feeds have commenced.
Intervention code [1] 314195 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319756 0
Sonographic appearance of neonatal bowel contents 10 to 14 days after initiation of fortified breastmilk feeds.
Timepoint [1] 319756 0
Participants will have completed practical participation once the second ultrasound has been performed (10-14 days after initiation of fortifier into the breastmilk feeds).
Secondary outcome [1] 369431 0
Nil
Timepoint [1] 369431 0
Nil

Eligibility
Key inclusion criteria
Babies will be eligible when they are born at <37 weeks’ gestation and/or of low birth weight (<1,800 g). They must be admitted to the NICU with the first abdominal ultrasound occurring before fortifier is added to the expressed breastmilk.
Minimum age
No limit
Maximum age
1 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion from recruitment:

- Exclusive formula feeding (or > 50%)
- Known chromosomal abnormality or heritable disease affecting gastrointestinal anatomy or function, or surgical gastrointestinal disease such as gastroschisis
- Lack of guardian consent (verbal or written)

Exclusion from analysis:

- Development of clinical bowel obstruction of any cause, or development of necrotising enterocolitis
- Abdominal or thoracic surgery
- Administration of medications that reduce gastrointestinal motility

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
A descriptive study (including representative radiological images) aimed at providing information toward future defined criteria for impending milk curd obstruction in neonates fed with fortified breastmilk feeds. In order to recognise the 'abnormal', one must first define the range of appearances of 'normal'.
Statistical analyses will not be required at completion.

20 neonates is a number that allows completion of the study within the set timeframe, based on the throughput of our neonatal intensive care.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/05/2019
Actual
Date of last participant enrolment
Anticipated
25/08/2019
Actual
Date of last data collection
Anticipated
8/09/2019
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 21404 0
New Zealand
State/province [1] 21404 0
Auckland

Funding & Sponsors
Funding source category [1] 302500 0
Self funded/Unfunded
Name [1] 302500 0
Dr Lara Kimble
Country [1] 302500 0
New Zealand
Funding source category [2] 302580 0
Hospital
Name [2] 302580 0
Starship Radiology, Auckland City Hospital (free use of an ultrasound machine)
Country [2] 302580 0
New Zealand
Primary sponsor type
Individual
Name
Dr Lara Kimble
Address
2 Park Road
Grafton
Auckland
1023
Country
New Zealand
Secondary sponsor category [1] 302407 0
None
Name [1] 302407 0
Address [1] 302407 0
Country [1] 302407 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303156 0
Health and Disability Ethics Committee (HDEC), Ministry of Health
Ethics committee address [1] 303156 0
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 303156 0
New Zealand
Date submitted for ethics approval [1] 303156 0
Approval date [1] 303156 0
11/03/2019
Ethics approval number [1] 303156 0
19/CEN/10

Summary
Brief summary
Premature babies receive fortified feeds to improve growth and optimal bone formation. However, this can lead to milk curd obstruction (MCO) in the bowel and, rarely, perforation of the bowel. Diagnosis of MCO is difficult as clinical findings and abdominal radiographs are often non-specific. As a result, a baby may undergo surgery to explore the abdomen or may see their (fortified) feeds stop even though this leads to sub-optimal nutrition.
Neonatal sonographic appearances of MCO in the bowel are not well-described; however, ultrasound has been suggested as the imaging choice for a milk curd in the stomach. This study aims to establish the ‘normal’ appearances of bowel contents on abdominal ultrasound in 20 asymptomatic babies admitted to the NICU born at <37 weeks’ gestation and fed on fortified breastmilk.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92674 0
Dr Lara Kimble
Address 92674 0
Auckland City Hospital
2 Park Road
Grafton
Auckland 1023
Country 92674 0
New Zealand
Phone 92674 0
+64 212146037
Fax 92674 0
Email 92674 0
milkcurdobstruction1@hotmail.com
Contact person for public queries
Name 92675 0
Dr Lara Kimble
Address 92675 0
Auckland City Hospital
2 Park Road
Grafton
Auckland 1023
Country 92675 0
New Zealand
Phone 92675 0
+64 212146037
Fax 92675 0
Email 92675 0
milkcurdobstruction1@hotmail.com
Contact person for scientific queries
Name 92676 0
Dr Lara Kimble
Address 92676 0
Auckland City Hospital
2 Park Road
Grafton
Auckland 1023
Country 92676 0
New Zealand
Phone 92676 0
+64 212146037
Fax 92676 0
Email 92676 0
milkcurdobstruction1@hotmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data essentially includes acquired images of the neonatal bowel. These will be best kept secure on site at the hospital. The Patient Consent Form authorises use of de-identified select images as illustrations within this descriptive study.
There would be no benefit to free access to these images by those not concerned with this study, and the patients' guardians will not have been consented for free dispersion of all their child's images.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1870Ethical approval    377404-(Uploaded-13-04-2019-11-32-36)-Study-related document.pdf
1871Study protocol    377404-(Uploaded-13-04-2019-11-33-12)-Study-related document.docx
1872Informed consent form    377404-(Uploaded-13-04-2019-11-33-46)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.