Condition category
Pregnancy and Childbirth
Date applied
02/10/2017
Date assigned
09/10/2017
Last edited
26/10/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Around 1-2% of babies are born at least eight weeks before their due date, making them very preterm. While medical advances have improved the survival chances of very preterm babies, their fragile health status places them at risk of brain injuries that can lead to learning difficulties. The considerable cost to the UK of supporting the special educational needs of very preterm children means that there is an urgent demand for effective treatments, especially ones that can be carried out during early infancy while the brain is still developing rapidly. Studies with three-month-old babies who were born full term have shown that they benefit from play involving ‘sticky mittens’. Sticky mittens are Velcro-covered mittens that can be used with Velcro-covered toys to enable babies who have not yet learned to reach for things to grab toys simply by swiping and touching them. Play experiences with sticky mittens give babies a head start in moving and exploring objects, activities that boost their learning. To date, however, sticky mittens have never been used with very preterm babies. The goal of our study is to find out whether sticky mittens can improve the intellectual, social and motor skills of very preterm babies. Arranging play activities for babies using sticky mittens is easy and inexpensive. If the mittens are found to be helpful to very preterm babies then their use could be recommended to parents as a simple means of supporting their child’s development.

Who can participate?
Very preterm babies aged three months relative to their due date, who have no obvious physical or sensory disabilities (e.g., cerebral palsy, blindness, deafness).

What does the study involve?
Participants are allocated randomly to one of two groups. In the first group, parents allow their baby to wear sticky mittens for up to 10 minutes per day for three weeks while interacting with Velcro-covered toys. In the second group, each baby wears ordinary mittens for up to 10 minutes per day for three weeks while watching their parent pick up the toys, move them around, and touch them to the palms of the baby’s hands. The two groups are compared from three to 15 months corrected age on tests of intellectual, social and motor development to see whether babies who wore sticky mittens show an advantage.

What are the possible benefits and risks of participating?
There are no direct benefits with participation. There are no foreseeable risks to the babies in either group from participating in this study. We are hopeful that experience with sticky mittens will be effective in improving the development of babies in the treatment group. In the long term, the results from this project will be used to inform parents of very preterm babies of ways they can enhance their child’s learning using simple play activities.

Where is the study run from?
The study is being run by Anglia Ruskin University and takes place in the Rosie Hospital in Cambridge (UK)(main recruiting site) and Peterborough City Hospital (UK) (secondary recruiting site).

When is the study starting and how long is it expected to run for?
February 2016 to December 2021

Who is funding the study?
Action Medical Research UK (UK)

Who is the main contact?
Dr Ruth Ford
ruth.ford@anglia.ac.uk

Trial website

https://www.action.org.uk/our-research/tackling-premature-birth

Contact information

Type

Public

Primary contact

Dr Ruth Ford

ORCID ID

http://orcid.org/0000-0002-0001-3720

Contact details

Department of Psychology
Anglia Ruskin University
East Road
Cambridge
CB1 1PT
United Kingdom
+44 1223 695125
ruth.ford@anglia.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

35419

Study information

Scientific title

Lending a helping hand to very preterm infants: A randomised controlled trial of the effectiveness of ‘sticky mittens’ for enhancing cognitive development from ages 3- to 15 months

Acronym

Study hypothesis

The aim of this study is to evaluate the effectiveness of sticky mittens, administered at 3-months corrected age, for improving the cognitive, motor, and social development of very preterm infants from 4- to 15-months corrected age.

Ethics approval

NHS Cambridgeshire and Hertfordshire Research Ethics, 02/10/2017, ref: 17/EE/0329

Study design

Randomised; Interventional; Design type: Prevention, Psychological & Behavioural

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Specialty: Reproductive health and childbirth, Primary sub-specialty: Other; UKCRC code/ Disease: Reproductive Health and Childbirth/ Other obstetric conditions, not elsewhere classified

Intervention

Participants are assigned to either the intervention group or the control group using stratified randomised sampling, the groups are matched for gender, and family socio-economic status (SES; low vs. average vs. high) as gauged by a parent-report demographics questionnaire administered at the time of recruitment.

Following the pre-intervention assessments, and using the pre-determined sequence for group allocation relevant to the family’s strata, the research assistance (RA) shows parents how to use the mittens and toys while seated at a table with the infant on their lap (supported by a pillow if necessary). They then video-record proceedings as the parent conducts their infant’s first play session. Subsequently, parents are asked to use the materials as instructed at home, 10 minutes per day for three weeks. Each session involves the parent putting the mittens (either sticky or non-sticky depending on group) on their baby’s hands before holding them on their lap and sitting at a low table on which they have placed the three sets of toys within reach of the baby. Parents are asked to video-record all mittens sessions using either a digital camera or mobile phone so that we can check the fidelity of the intervention, and to record the length of each session in a daily log book. The RA visits the family 7- and 14 days later. During these visits, they video-record the infant's progress in using the mittens. They answer any questions that the parents may have and (if necessary) conduct further training in the use of the mittens.

In the intervention group, the babies wear sticky mittens. Parents are asked to encourage their child to explore each set of toys in turn (with timing and order variable across sessions), for example, by tapping the toys or guiding the infant’s hand towards the toys until contact is made. They are also advised to praise the infant for inspecting the toys. It is made clear that after infants have mastered the technique of touching and manipulating the toys, parents should allow them to take the initiative in selecting items to explore. If the infant makes contact with an object then the parent should remove the toy from the mitten and place it back on the table to allow them to try again.

In the control group, the babies wear non-sticky mittens and they simply observe the toys being moved and touched to their palms by their caregiver. As for the intervention group, parents are requested to draw the infant’s attention to different sets of toys in turn and to offer verbal encouragement for inspecting them.

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Cognitive development is measured using the Bayley Scales of Infant and Toddler Development 3rd Edition (Bayley-III) at 3- and 15 months of age, and observational tests of exploratory/reaching behaviour at three, four, eight and 15 months of age
2. Motor development is assessed using the Bayley Scales of Infant and Toddler Development 3rd Edition (Bayley-III) at three and 15 months of age, and the parent-report Early Motor Questionnaire (EMQ) at three and 15 months of age
3. Social development is assessed via habituation tests of attention (measuring infants’ looking time in seconds) to images of human faces and hands at fouur and eight months of age, the Early Social Communication Scales (ESCS) at 15 months of age, and the parent-report Early Childhood Behaviour Questionnaire (ECBQ) at 15 months of age

Secondary outcome measures

Parent levels of confidence and stress in interacting with their very preterm baby is measured using the parent-report Interacting with my Premature Infant Questionnaire (IPIQ) at three months of age, and the parent-report Parenting Stress Index (PSI) at 15 months of age.

Overall trial start date

01/02/2016

Overall trial end date

31/12/2021

Reason abandoned

Eligibility

Participant inclusion criteria

1. Babies who were born very preterm or nearly so (i.e., ≤ 33 weeks gestation)
2. Babies who are free of major sensory and physical disabilities (e.g., blindness, deafness)
3. Babies who are living within the study catchment area
4. Babies whose parents/caregivers are fluent English speakers
5. Babies who have reached 3-months corrected age
6. Both boys and girls are eligible

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 60; UK Sample Size: 60

Participant exclusion criteria

1. Babies with major sensory or physical disability (e.g., blindness, deafness)
2. Babies participating in another clinical trial
3. Babies living outside the project catchment area
4. Babies whose parents are not fluent English speakers

Recruitment start date

01/01/2018

Recruitment end date

31/12/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Anglia Ruskin University
Department of Psychology East Road
Cambridge
CB1 1PT
United Kingdom

Trial participating centre

Rosie Maternity Hospital
Robinson Way
Cambridge
CB2 0SW
United Kingdom

Trial participating centre

Peterborough City Hospital
Edith Cavell Campus Bretton Gate
Peterborough
PE3 9GZ
United Kingdom

Sponsor information

Organisation

Anglia Ruskin University

Sponsor details

East Road
Cambridge
CB1 1PT
United Kingdom
+44 1245 493131
answers@anglia.ac.uk

Sponsor type

Hospital/treatment centre

Website

http://www.anglia.ac.uk

Funders

Funder type

Government

Funder name

Action Medical Research

Alternative name(s)

AMR

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal. A protocol can be made available later.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/01/2022

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

26/10/2016: Internal review.