title: PREMM: preterm early massage by the mother: protocol of a randomised controlled trial of massage therapy in very preterm infants.
abstract: Preterm infants follow an altered neurodevelopmental trajectory compared to their term born peers as a result of the influence of early birth, and the altered environment. Infant massage in the preterm infant has shown positive effects on weight gain and reduced length of hospital stay. There is however, limited current evidence of improved neurodevelopment or improved attachment, maternal mood or anxiety. The aim of this study is to investigate the effects of infant massage performed by the mother in very preterm (VPT) infants. Effects on the infant will be assessed at the electrophysiological, neuroradiological and clinical levels.  Effects on maternal mood, anxiety and mother-infant attachment will also be measured.
  
  
  
  A randomised controlled trial to investigate the effect of massage therapy in VPT infants. Sixty VPT infants, born at 28 to 32 weeks and 6 days gestational age, who are stable, off supplemental oxygen therapy and have normal cranial ultrasounds will be recruited and randomised to an intervention (infant massage) group or a control (standard care) group. Ten healthy term born infants will be recruited as a reference comparison group. The intervention group will receive standardised massage therapy administered by the mother from recruitment, until term equivalent age (TEA). The control group will receive care as usual (CAU). Infants and their mothers will be assessed at baseline, TEA, 12 months and 24 months corrected age (CA), with a battery of clinical, neuroimaging and electrophysiological measures, as well as structured questionnaires, psychoanalytic observations and neurodevelopmental assessments.
  
  
  
  Optimising preterm infant neurodevelopment is a key aim of neonatal research, which could substantially improve long-term outcomes and reduce the socio-economic impact of VPT birth. This study has the potential to give insights into the mother-baby relationship and any positive effects of infant massage on neurodevelopment. An early intervention such as massage that is relatively easy to administer and could alter the trajectory of preterm infant brain development, holds potential to improve neurodevelopmental outcomes in this vulnerable population.
  
  
  
  Australian New Zealand Clinical Trials Registry: ACTRN12612000335897 . Date registered: 22/3/2012.
authors: Perinatal Research Centre, School of Medicine, Royal Brisbane & Women's Hospital, Brisbane, Qld, Australia.|University of Queensland Centre for Clinical Research, Level 4, Bldg 71/918, Royal Brisbane & Women's Hospital, Brisbane, Qld, Australia.|Grantley Stable Neonatal Unit, Royal Brisbane & Women's Hospital, Brisbane, Qld, Australia.
authors: Melissa M
authors: MM
authors: Lai
authors: Stella Maris Institute, The University of Pisa, Pisa, Italy.
authors: Giulia
authors: G
authors: D'Acunto
authors: Stella Maris Institute, The University of Pisa, Pisa, Italy.
authors: Andrea
authors: A
authors: Guzzetta
authors: Queensland Cerebral Palsy and Rehabilitation Research Centre, School of Medicine, Faculty of Medicine and Biomedical Sciences, The University of Queensland, Brisbane, Qld, Australia.
authors: Roslyn N
authors: RN
authors: Boyd
authors: CSIRO, Australian e-Health Research Centre, Royal Brisbane and Women's Hospital, Brisbane, Qld, Australia.
authors: Stephen E
authors: SE
authors: Rose
authors: CSIRO, Australian e-Health Research Centre, Royal Brisbane and Women's Hospital, Brisbane, Qld, Australia.
authors: Jurgen
authors: J
authors: Fripp
authors: Perinatal Research Centre, School of Medicine, Royal Brisbane & Women's Hospital, Brisbane, Qld, Australia.|University of Queensland Centre for Clinical Research, Level 4, Bldg 71/918, Royal Brisbane & Women's Hospital, Brisbane, Qld, Australia.
authors: Simon
authors: S
authors: Finnigan
authors: Grantley Stable Neonatal Unit, Royal Brisbane & Women's Hospital, Brisbane, Qld, Australia.
authors: Naoni
authors: N
authors: Ngenda
authors: Perinatal Research Centre, School of Medicine, Royal Brisbane & Women's Hospital, Brisbane, Qld, Australia.|University of Queensland Centre for Clinical Research, Level 4, Bldg 71/918, Royal Brisbane & Women's Hospital, Brisbane, Qld, Australia.
authors: Penny
authors: P
authors: Love
authors: Queensland Cerebral Palsy and Rehabilitation Research Centre, School of Medicine, Faculty of Medicine and Biomedical Sciences, The University of Queensland, Brisbane, Qld, Australia.
authors: Koa
authors: K
authors: Whittingham
authors: CSIRO, Australian e-Health Research Centre, Royal Brisbane and Women's Hospital, Brisbane, Qld, Australia.
authors: Kerstin
authors: K
authors: Pannek
authors: UQ Child Health Research Centre, School of Medicine, The University of Queensland, Brisbane, Qld, Australia.|School of Population Health, The University of Queensland, Brisbane, Qld, Australia.
authors: Robert S
authors: RS
authors: Ware
authors: Perinatal Research Centre, School of Medicine, Royal Brisbane & Women's Hospital, Brisbane, Qld, Australia. p.colditz@uq.edu.au.|University of Queensland Centre for Clinical Research, Level 4, Bldg 71/918, Royal Brisbane & Women's Hospital, Brisbane, Qld, Australia. p.colditz@uq.edu.au.|Grantley Stable Neonatal Unit, Royal Brisbane & Women's Hospital, Brisbane, Qld, Australia. p.colditz@uq.edu.au.
authors: Paul B
authors: PB
authors: Colditz
mesh_terms: D000328:Adult; D002657:Child Development; D002985:Clinical Protocols; D004569:Electroencephalography; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007224:Infant Care / Q000379:methods* / Q000523:psychology; D007231:Infant, Newborn; D007234:Infant, Premature / Q000502:physiology / Q000523:psychology; D008279:Magnetic Resonance Imaging; D008405:Massage / Q000379:methods* / Q000523:psychology; D009034:Mother-Child Relations / Q000523:psychology; D009035:Mothers / Q000523:psychology; D059906:Neuroimaging; D009769:Object Attachment; D011581:Psychological Tests; D016037:Single-Blind Method
keywords: Attachment; Infant massage; Neurodevelopment; Preterm