Background
Activity/assessment | Staff member | Approximate time to complete | Before delivery | t0 | t1 | t2 | t3 | t4 | t5 | t6 | t7 | t8 | t9 | t10 | t11 | t12 | t13 | t14 |
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Informed consent | Neonatal nurse/physician | 15 minutes | x | |||||||||||||||
Inclusion/exclusion form | Neonatal nurse | 5 minutes | x | |||||||||||||||
Randomization sealed envelopes | Neonatal nurse | 1 minute | x | |||||||||||||||
Heart rate | Neonatal nurse | 30 sec | x | x | x | x | x | |||||||||||
Respiration rate | Neonatal nurse | 30 sec | x | x | x | x | x | |||||||||||
Oxygen saturation | Neonatal nurse | 30 sec | x | x | x | x | x | |||||||||||
Body temperature | Neonatal nurse | 30 sec | x | x | x | x | x | x | ||||||||||
Blood glucose | Neonatal nurse | 5 minutes | x1 | x1 | x | x | ||||||||||||
Blood pressure | Neonatal nurse | 5 minutes | x | x | x | |||||||||||||
Maternal anxiety (STAI) | Study coordinator | 15 minutes | x | x | x | |||||||||||||
Ages & Stages Questionnaire | Study coordinator | 15 minutes | x | x | ||||||||||||||
General movement (GMA) | Study coordinator | 5 minutes | x | |||||||||||||||
Bayley Scale of Infant and Toddler Development III | Occupational therapist | 60 minutes | x | x |
Aims
Primary aim
Secondary aims
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To assess safety of the intervention by measuring incidence of hypothermia (temperature <36 °C) or respiratory failure during the first 2 hours of life.
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To estimate the effect of the intervention on complications to prematurity (intraventricular hemorrhage (IVH) or periventricular leukomalacia (PVL), seizures, necrotizing enterocolitis (NEC), treatment for persistent ductus arteriosus (PDA), and bronchopulmonary dysplasia (BPD)).
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To estimate the effect of the intervention on physiological stability during the first 24 hours.
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To estimate the effect of the intervention on maternal mental health at discharge from the NICU and when the child’s corrected age is 3 months and again at the corrected age of 2 years by using the State-Trait Anxiety Inventory (STAI).
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To investigate if the intervention affects the fidgety type of general movements and detailed aspects of the early motor repertoire at the corrected age of 3 months, using the General Movement Assessment (GMA) and the Assessment of Motor Repertoire – 2 to 5 months (AMR).
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To estimate the effect of the intervention on neurodevelopmental outcomes including cognition, language, and motor function at the corrected age of 1 year, and language and motor function at the corrected age of 2 years assessed with Bayley-III.
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To investigate the effect of the intervention on social and emotional competence at the corrected age of 3 months and at 2 years with the Ages & Stages Questionnaire - Social-Emotional