None listed
Conditions
Brief summary
We aim to test how practical and acceptable it is to deliver a very early developmental program over a 12 week period. The program is designed for healthy moderate to late preterm (born between 32-36 weeks gestation) who are 3-month-old. The study has three parts; Pre-intervention assessment (including a gross motor and neurological screening assessment), NEOgrads Playgroup intervention that includes a weekly playgroup (30- minutes) and personalised developmental home program, and a Post-intervention assessment (re-measure of the gross motor assessment). Parents / caregivers will also be asked to complete a logbook of their home exercise program practice over the intervention period and be asked to complete a parent satisfaction questionnaire.
Interventions
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.
Sponsors
Study design
Eligibility
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.
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.