Trial Review

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
ACTRN12616000313437
Ethics application status
Approved
Date submitted
4/03/2016
Date registered
10/03/2016
Date last updated
10/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can electrogastrography (EGG) detect abnormal activity of the stomach in babies with feeding difficulties
Scientific title
Continuous wavelet analysis of postprandial EGGs suggests sustained gastric slow waves may be slow to develop in infants with colic
Secondary ID [1] 288690 0
Nil known
Universal Trial Number (UTN)
U1111-1180-3170
Trial acronym
CBS (Colicky baby study)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colic (gastric motility disorders) in infants 297904 0
Condition category
Condition code
Oral and Gastrointestinal 298070 298070 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Exclusively breast-fed, non-colicky babies and exclusively breast-fed babies diagnosed with infant colic were recruited by advertisement. The mothers of those with infant colic completed a questionnaire regarding symptomatology.
A respiratory belt (ADInstruments MLT1132; Sydney, Australia) was placed around the mid-thorax of the baby. EGG recordings were taken from an array of adherent bipolar silver/silver chloride electrodes (Ambu N-00-S/25; Copenhagen, Denmark) applied to the anterior surface of the stomach. A total of 6 electrodes (4 recording, 1 common, 1 earth) were applied and connected to an electrically isolated recorder (AD Instruments Octal Bioamp ML138 and 8/SP Powerlab A/D converter; Sydney, Australia). Voltage readings from the respiratory belt and EGG recordings were for 3.5 hours (one recording per baby), based on previous research, including whilst the baby was sleeping after feeding
Intervention code [1] 294116 0
Early Detection / Screening
Comparator / control treatment
EGG recordings from 23 breast fed colicky infants would be compared with a control group of 26 breast fed non-colicky infants using wavelet analysis
Control group
Active

Outcomes
Primary outcome [1] 297587 0
To determine whether analysis of the EGG signal by CWT, could detect abnormal electrophysiological activity in babies with infant colic.
Timepoint [1] 297587 0
Voltage readings from the respiratory belt and EGG recordings were taken for periods of up to 3.5 hours, including whilst the baby was sleeping after feeding.
Secondary outcome [1] 321514 0
NA
Timepoint [1] 321514 0
NA

Eligibility
Key inclusion criteria
Infants recruited had ongoing signs of colic as diagnosed by a clinician and were screened by questionnaire to ensure that the child exhibited one or more of the reported characteristics; paroxysmal crying of a higher pitch with more tenseness and irregularity, paroxysmal crying particularly in the evening, paroxysmal crying for periods of more than 3 hours per day, paroxysmal crying for more than 3 days per week and paroxysmal crying more than three weeks duration, paroxysmal crying commencing during the first week of life and peaking during the second month of life. Infants recruited in the control group had no signs of colic as diagnosed by a clinician and were screened by a questionnaire to ensure that the child did not exhibit any of the above reported charachteristics
Minimum age
1 Months
Maximum age
4 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Infants who were mechanically unwell

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis
No power calculations were done as no one has previously studies the condition in infants with colic. The number of subjects were chosen based on an initial pilot study conducted by the group to determine the incidence of colic in infants. The initial pilot study did show that there is an underlying disorder but higher numbers of subjects were needed to provide a suitable basis for a power analysis to predict numbers in the current experimental context. Data was analysed by multivariate statistics
Differences between overall means of frequency, overall standard deviations, numbers of frequency values that fell below one standard deviation of the overall mean frequency and numbers of frequency values that were above one standard deviation from the overall mean frequency in the colicky and non-colicky groups were each compared by ANOVA.The pattern of variation of the three parameters between the two treatment groups was also explored by multivariate (discriminant) analysis. Both classical linear and quadratic models for discriminant analyses were employed, the latter to account for any departure from bivariate normal distribution

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
25/02/2013
Date of last participant enrolment
Anticipated
Actual
4/12/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
49
Recruitment outside Australia
Country [1] 7639 0
New Zealand
State/province [1] 7639 0
Wellington, Hawkesbay, Rangitekei, Tararua, Manawatu

Funding & Sponsors
Funding source category [1] 293048 0
Commercial sector/Industry
Name [1] 293048 0
Fonterra Co-operative Group Limited
Country [1] 293048 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
Massey University (Turitea), Tennent drive, Palmerston North 4474
Country
New Zealand
Secondary sponsor category [1] 291827 0
None
Name [1] 291827 0
Address [1] 291827 0
Country [1] 291827 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294559 0
Massey University Human Ethics Committee: Southern A
Ethics committee address [1] 294559 0
Human Ethics Research Office, Courtyard Complex, Manawatu Campus, Massey University, Private bag 11222, Palmerston North 4442
Ethics committee country [1] 294559 0
New Zealand
Date submitted for ethics approval [1] 294559 0
Approval date [1] 294559 0
10/07/2013
Ethics approval number [1] 294559 0
09/80

Summary
Brief summary
The aetiology of infant colic is poorly understood with little evidence regarding the development of gastric and intestinal motility. Its occurrence is a common concern to nursing mothers particularly in view of the fact that there are currently no tests that can readily distinguish any underlying pathology. The aim of the current work was to determine the incidence of gastric rhythm disorders in infants by comparing electrogastrography (EGG) signals by continuous wavelet analysis, to compare EGG patterns of non colicky versus colicky infants. Post prandial EGG recordings were obtained from 1) 26 breast fed non-colicky infants and 2) 23 breast fed colicky infants.
Trial website
Trial related presentations / publications
NA
Public notes
The study was first approved by Massey University Human Ethics Committee: Southern A 09/80 on 01/03/2010. An amendment o the trial was resubmitted to MUHEC on the 10th of July 2013 and received approval on 10/07/2013 .

Contacts
Principal investigator
Name 64142 0
Dr Roger Lentle
Address 64142 0
Massey University Massey Institute of Food Science and Technology, School of Food and Nutrition College of Health Private bag 11222 Palmerston North 4442,
Country 64142 0
New Zealand
Phone 64142 0
+64 (0)6 350 81402
Fax 64142 0
+64 (0)6 350 5657
Email 64142 0
[email protected]
Contact person for public queries
Name 64143 0
Dr Roger Lentle
Address 64143 0
Massey University Massey Institute of Food Science and Technology, School of Food and Nutrition College of Health Private bag 11222 Palmerston North 4442,
Country 64143 0
New Zealand
Phone 64143 0
+64 (0)6 350 81402
Fax 64143 0
+64 (0)6 350 5657
Email 64143 0
[email protected]
Contact person for scientific queries
Name 64144 0
Dr Roger Lentle
Address 64144 0
Massey University Massey Institute of Food Science and Technology, School of Food and Nutrition College of Health Private bag 11222 Palmerston North 4442,
Country 64144 0
New Zealand
Phone 64144 0
+64 (0)6 350 81402
Fax 64144 0
+64 (0)6 350 5657
Email 64144 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseContinuous wavelet analysis of postprandial EGGs suggests sustained gastric slow waves may be slow to develop in infants with colic.2017https://dx.doi.org/10.1111/nmo.12948
N.B. These documents automatically identified may not have been verified by the study sponsor.