Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000842561
Ethics application status
Approved
Date submitted
9/06/2024
Date registered
8/07/2024
Date last updated
8/07/2024
Date data sharing statement initially provided
8/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The NEOgrads playgroup program- promoting early motor development for preterm babies.
Scientific title
The NEOgrads playgroup study: Improving developmental motor outcomes through intensive Early Intervention in preterm infants: A feasibility study.
Secondary ID [1] 312030 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy preterm infants (32+0 to 36+6 weeks gestation). 332114 0
Gross motor developmental delay 333638 0
Cognitive Delay 334120 0
Preterm infants 334121 0
Condition category
Condition code
Reproductive Health and Childbirth 328843 328843 0 0
Complications of newborn
Public Health 328844 328844 0 0
Health service research
Neurological 330974 330974 0 0
Other neurological disorders
Mental Health 330975 330975 0 0
Learning disabilities
Musculoskeletal 330976 330976 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will participate in a 12-week developmental Early Intervention program (NEOgrads playgroup), including a pre and post intervention gross motor assessment to determine the programs feasibility. The NEOgrads program will consist of a weekly, 30-minute developmental group class with and a tailored home exercise program (daily practice for 20 minutes duration) for 12-weeks intervention period. Following the initial baseline assessment, a personalised developmental home program will be provided to the participants caregivers by the primary investigator, a trained Paediatric Physiotherapist who is experienced working with NICU graduates and promoting infant development. This will be in paper format and include photo examples of the developmental exercises (generic photos) based on identified areas requiring development from the baseline assessment (conducted by an external developmental research therapist).

The NEOgrads playgroup classes will be hosted and run by the primary investigator who is a trained paediatric physiotherapist. Once weekly, 30-minute developmental class sessions will be held in a local community center (community room, hall or church) or at Auckland Children’s Physiotherapy rooms (enable three different geographical localities) with free and accessible parking within close vicinity. We will aim to run classes with five infants per week, with a minimum of two infants in one class (scheduled class) on a assigned day (same class time and day of week for 12 weeks). To accommodate infants missing a class, an additional two extra infants can attend a class outside of their normal session (make up class) to raise class maximum to seven. Following the baseline assessment (pre-intervention 11-12 week gestational age assessment), Parents/ caregivers will discuss with research therapist the most suitable (geographical location/ time) of set assigned group classes and be notified of confirmation of assigned class by phone and email by the primary investigator.
Parents/ caregivers will also be provided with information on class location (address), parking options, notification of illness or required change of class due to appointments etc and how to contact the primary investigator who will be hosting all the classes.

The participants will attend the same developmental class each week with the same group of participants and their family. Parents will be encouraged to be actively involved with support and mentoring provided by the physiotherapist to practice developmental exercises with their infant. The infant’s home exercise program will be updated (paper exercise program and practice of new exercises during class) with improvements in infant’s developmental skills by primary investigator running the group classes. During the duration of the class, infant development and motor skill acquisition will be discussed to build parents confidence and application to their own infant development and will support prescribed home program that will be recorded for reporting. Home practice will be encouraged with a duration of 20 minutes daily, with a minimum of 4 separate days of practice over a week.

Participants caregivers will be required to complete a "Parent Logbook". This will record home practice (the frequency and duration) and additional external developmental activities completed during the intervention period. This will be used to help measure program adherence in addition to participant attendance to the playgroup class sessions. If parents/ caregivers are not able to attend or need to communicate with the class coordinator, the direct mobile and email will be provided in the initial booking email and follow up reminder emails as discussed above. A group reminder will be sent 48 hours prior to each weekly class by the primary investigator.

At the completion of the study, the parents/ caregivers will be asked to complete a survey including a series of customised “Parent- rated satisfaction” questions using a 5-point Likert scale and open-ended questions regarding the acceptability of the NEOgrads playgroup program. This will be used to help determine the programs acceptability to participants families.

During the class sessions, the primary investigator will complete a "Playgroup Logbook" to record participant attendance to the NEOgrads playgroup after each session.

Protocol fidelity will be measured using a class protocol audit. The first three weeks of classes will be video recorded to audit the consistency of protocol delivery. In addition, the primary investigator will complete a check list following each class to monitor the delivery and practice of key motor performance exercises as outlined in the weekly session plan (Intervention protocol). If significant changes to the protocol occur, an additional three weeks of video recording of class sessions will be completed and audited. Consent will be checked at each planned video recording class to ensure any new parent/caregiver attendees have provided informed written consent.

Limited efficacy testing will be completed using baseline (pre intervention assessment at 11 weeks corrected age) and post intervention (6 months of age post completion of the 12 week program) developmental changes in gross motor development measured using The Peabody Developmental Motor Scale (PDMS-2). There will be no control group for comparison but a clinically significant improvement of 1 standard deviation in Gross Motor Quotient scores as set by Darrah et al. The PDMS-2 will be completed by the independent research therapist who is not involved with class intervention delivery.
Intervention code [1] 327444 0
Rehabilitation
Intervention code [2] 327445 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338076 0
Feasibility: program adherence
Timepoint [1] 338076 0
The "Playgroup Logbook" will be updated following each class session over the 12 week program.
The "Parent Logbook" will be completed following practice at home.
Secondary outcome [1] 434396 0
Feasibility: Protocol fidelity
Timepoint [1] 434396 0
Following each class session over the first 3 weeks of each class group during the 12-week intervention period.
Video analysis of class session at the end of the class day.
Secondary outcome [2] 434397 0
Feasibility: Program acceptability
Timepoint [2] 434397 0
Immediately following 12-week intervention period. This will be provided in paper form on the last class day for the participant.
Secondary outcome [3] 434398 0
Feasibility: Limited efficacy testing
Timepoint [3] 434398 0
Completed at enrollment to NEOgrads study at 11-12 weeks corrected age, and directly following the NEOgrads 12 week intervention, when infants are 6 to 7 months corrected age. .

Eligibility
Key inclusion criteria
To be eligible for the study, participants will satisfy the following criteria:
-Be healthy preterm infants who have been born between 32+0 to 36+6 weeks post-menstrual age,
-Infant is younger than 12-weeks corrected age (based on estimated date of birth),
-Reside in the Auckland region who have English-speaking parents/ caregivers.
Minimum age
11 Weeks
Maximum age
7 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Potential participants will be excluded if they meet the following criteria:
-Infants born extremely preterm, i.e., < 32 weeks gestation,
-Infants with known genetic or neurological conditions that will affect gross motor development (i.e., Trisomy 21, arthrogryposis, Cerebral Palsy, Spina Bifida, etc),
-Parents/ caregivers who are unable to bring the infant in-person to the intervention classes and the two assessments,
-Infants who require oxygen support, nasal gastric tube feeding or are acutely unwell.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 15 infants was selected for this feasibility pilot study based on similar participation recruitment in Early Intervention pilot studies (N= 6-14) in Early Intervention arm).

Feasibility measures of adherence and intervention fidelity will be determined through descriptive analysis (mean, percentage). Program acceptability will be assessed using two different processes, the Likert scale will be analysed using descriptive statistics (mean, percentage). Whilst the targeted open-ended data of the parent-rated satisfaction survey (question 8-11) will be evaluated using direct content analysis.

Participant characteristics will be analysed to show frequency, percentages, mean and minimum and maximum values.

Data from infants who were not able to attend 60% of the in-person sessions will be excluded from analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/07/2024
Actual
Date of last participant enrolment
Anticipated
16/08/2024
Actual
Date of last data collection
Anticipated
30/11/2024
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment outside Australia
Country [1] 26281 0
New Zealand
State/province [1] 26281 0
Auckland

Funding & Sponsors
Funding source category [1] 316380 0
Other Collaborative groups
Name [1] 316380 0
Physiotherapy New Zealand Special Interest Groups (Neurology & North Shore Branch)
Country [1] 316380 0
New Zealand
Funding source category [2] 316381 0
Other Collaborative groups
Name [2] 316381 0
Visiting Neurodevelopmental Therapists New Zealand Group
Country [2] 316381 0
New Zealand
Funding source category [3] 316382 0
Commercial sector/Industry
Name [3] 316382 0
Auckland Children's Physiotherapy Ltd.
Country [3] 316382 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
Country
New Zealand
Secondary sponsor category [1] 318563 0
Commercial sector/Industry
Name [1] 318563 0
Auckland Children's Physiotherapy ltd.
Address [1] 318563 0
Country [1] 318563 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314190 0
Northern A Health and Disability Ethics Committee 
Ethics committee address [1] 314190 0
Ethics committee country [1] 314190 0
New Zealand
Date submitted for ethics approval [1] 314190 0
01/12/2023
Approval date [1] 314190 0
05/04/2024
Ethics approval number [1] 314190 0
2024 FULL 15231
Ethics committee name [2] 315188 0
Auckland University of Technology Ethics Committee
Ethics committee address [2] 315188 0
Ethics committee country [2] 315188 0
New Zealand
Date submitted for ethics approval [2] 315188 0
10/04/2024
Approval date [2] 315188 0
28/05/2024
Ethics approval number [2] 315188 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130730 0
Dr Nusratnaaz Shaikh
Address 130730 0
Auckland University of Technology, 90 Akoranga Drive, Northcote Auckland 0627
Country 130730 0
New Zealand
Phone 130730 0
+64223036995
Fax 130730 0
Email 130730 0
[email protected]
Contact person for public queries
Name 130731 0
Louise Pearce
Address 130731 0
Auckland University of Technology, 90 Akoranga Drive, Northcote, Auckland 0627
Country 130731 0
New Zealand
Phone 130731 0
+64221551677
Fax 130731 0
Email 130731 0
[email protected]
Contact person for scientific queries
Name 130732 0
Nusratnaaz Shaikh
Address 130732 0
Auckland University of Technology, 90 Akoranga Drive, Northcote Auckland 0627
Country 130732 0
New Zealand
Phone 130732 0
+64223036995
Fax 130732 0
Email 130732 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All de-identified individual line-by-line data.
When will data be available (start and end dates)?
Immediately following publication, with no end date determined.
Available to whom?
Researchers providing robust proposal for data use.
Available for what types of analyses?
IPD meta-analysis.
How or where can data be obtained?
Contacting the co-investigator Louise Pearce on [email protected] and Dr Nusratnaaz Shaikh on [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
22399Study protocol    386918-(Uploaded-09-06-2024-18-37-59)-NEOgrads Research protocol V1.6.pdf
22400Informed consent form    386918-(Uploaded-09-06-2024-18-37-59)-NEOgrads Participant information sheet Parent V1.7 Final.pdf
22401Informed consent form    386918-(Uploaded-09-06-2024-18-37-59)-NEOgrads Participant information sheet Assent V1.4 AUTECH LP.pdf
23863Ethical approval    Locality approval at Auckland University of Techno... [More Details] 386918-(Uploaded-09-06-2024-18-38-39)-AUTEC approval 24.pdf
23864Ethical approval    386918-(Uploaded-09-06-2024-18-38-53)-HDEC approval letter.pdf
23865Other    Participant Flyer 386918-(Uploaded-09-06-2024-18-39-39)-Neograds study poster V1.2.pdf
23933Other    386918-(Uploaded-18-06-2024-18-27-10)-NEOgrads exercise handout example.pdf
23961Other    Parent-rated survey 386918-(Uploaded-06-07-2024-19-27-56)-NEOgrads Parent Caregiver Survey V1.1 .pdf



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.