None listed
Conditions
Brief summary
Preterm birth can be associated with long-term neurodevelopment abnormalities. This is at least partly explained by the detrimental effects of a highly stressful environment and the lack of tactile stimulation normally experienced in the womb. Infant massage has been shown to accelerate brain development, resulting in a pattern more similar to that observed in term-born infants. We will teach mothers to directly perform massage as part of the intervention program, and the short term effects of infant massage on brain structure will be examined through advanced neuroimaging techniques. We will recruit 40 preterm infants, and we will randomly allocate them to one of two groups (intervention or control group). 10 healthy newborns will also be recruited to serve as a typically developing comparison group. Short term effects on mother's mood and anxiety and on mother-infant bonding will also be explored by structured scales and questionnaires. Long term outcome measures will assess child development, parent child interaction and parental pyshological, social and emotional problems.
Interventions
Arm 1
Intervention Group - Preterm Infants
A massage paradigm modified from the preterm massage
protocol of Tiffany Fields will be taught via one-on-one sessions to the mothers of the intervention group administered by a physiotherapist. Teaching sessions will start at day 12 of life. For each mother, 3 teaching sessions will be needed to explain the entire massage protocol. These sessions will last for approximately 45 mins per day over three consecutive days (days 12, 13 and 14 of life). Moth
Arm 1 Intervention Group - Preterm Infants A massage paradigm modified from the preterm massage protocol of Tiffany Fields will be taught via one-on-one sessions to the mothers of the intervention group administered by a physiotherapist. Teaching sessions will start at day 12 of life. For each mother, 3 teaching sessions will be needed to explain the entire massage protocol. These sessions will last for approximately 45 mins per day over three consecutive days (days 12, 13 and 14 of life). Mothers will be asked to perform a minimum of one and a maximum of three massage sessions per day. Massage sessions will be preferably performed around 60 mins before feeding and at least 2 hours after the completion of the previous session. Each session will be subdivided into two parts. The first part will consist of a tactile stimulation: the infant will be gently placed prone and will be given moderate pressure stroking with the flats of the fingers. Head, neck, shoulders, buttocks, and both legs and arms will be stimulated. The second part will consist of a kinesthetic (motor) stimulation: the infant will be placed in a supine position and passive flexion/extension movements of the limbs in sequence will be provided. The mother will be specifically taught how to perceive newborn's feedbacks on the availability for receiving the massage. In the absence of availability by the newborn, mothers will put their hands in resting position. The approximate minimal duration of the protocol will be of 10 minutes for the first part and 5 minutes for the second part. A diary of time, number and duration of each session will be kept by the mothers for the duration of the intervention which will be the period from day 12 of life to term born equivalent age (approximately 42 weeks post menstrual age). Depending on the gestational age of the baby the duration of the intervention would be about 6-7 weeks. Infants of the control group will undergo routine care intervention.
Sponsors
Naoni Ngenda
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
28 Weeks to 33 Weeks
Healthy volunteers
No
Inclusion criteria
1) gestational age must be between 28 weeks and 32.6 weeks for group 1 and 2 babies 2) birthweight above 10th percentile 3) clinically stable and not on oxygen therapy 4) they present no brain abnormalities on brain ultrasound 5) they present with no major genetic disorders or malformations 6) they are a singleton 7) reside within 100km and willing to return for followup 8) group 3 babies need to have a gestational age of at least 37 weeks
Exclusion criteria
1) birthweight below 10th percentile 2) clinically unstable and on oxygen therapy 3) they present with brain abnormalities on brain ultrasound 4) they present with major genetic disorders or malformations 5) they are not a singleton 6) reside outside of 100km. 7) gestational age greater than 33 weeks or less than 26.6 weeks
Outcome results
None listed