How family involvement in tummy time influences head shape and infant development

Authors
Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2026
INTERVENTION: This is a randomized clinical trial in which participant allocation will be concealed from the researchers using sequentially numbered, sealed, opaque envelopes; the sequence in which the envelopes are opened will determine the allocation of each newborn. The study will include 78 term infants (gestational age greater than or equal to 37 weeks) allocated into two groups of 39 infants each. Experimental group: the families of 39 infants will receive guidance to perform daily tummy time, starting with 3‐minute sessions and progressively increasing to 30 minutes until the infant reaches 6 months of age. To support this process, a communication channel via WhatsApp® or Telegram® will be provided, according to the family's preference, to answer questions. In addition, up to 3‐minute demonstrative videos with tips on positioning and optimizing the practice for each age group will be sent every four weeks. Furthermore, at the same time the videos are sent (every four weeks), video calls will be conducted at previously agreed‐upon times until the sixth month of life, allowing the family to demonstrate progress or difficulties encountered. Control group: the families of 39 infants will receive the maternity ward's usual discharge guidance, which includes an explanatory leaflet on breastfeeding and infant hygiene. The experimental group will receive the tummy time stimulus. The groups will be compared using the following scales: the Argenta visual scale, three‐dimensional cranial scanning, the Alberta infant motor scale, the Hammersmith neurological examination, and the Bayley scales of infant development, in order to compare cranial morphology and global development between the groups CONDITION: plagiocephaly ; congenita lmusculoskeletal deformities of the head, face, spine, and thorax PRIMARY OUTCOME: It is expected that the experimental group will exhibit improved cranial morphology, characterized by reduced severity of cranial asymmetries compared with the control group at 28 days and at 3, 6, 9, and 12 months of age, as evidenced by lower measurement values obtained using Shining 3D scanners and the Baby Symmetry application, in addition to lower scores on the Argenta Scale.; SECONDARY OUTCOME: It is expected that the experimental group will demonstrate improved neurological development, as reflected by higher scores on the Hammersmith Infant Neurological Examination (HINE) compared with the control group at 3 and 9 months of age. ; It is expected that the intervention group will demonstrate improved global developmental outcomes, as reflected by higher scores on the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley‐III), compared with the control group at 6 and 12 months of age. ; ; It is expected that the intervention group will demonstrate improved motor development outcomes, as reflected by higher Alberta Infant Motor Scale (AIMS) percentile scores compared with the control group at 3, 6, 9, and 12 months of age. ; INCLUSION CRITERIA: Term‐born infants (gestational age between 37 weeks and 41 weeks and 6 days); aged 0 to 28 days at inclusion; with no known comorbidities (such as syndromes, genetic disorders, or neurological conditions that may affect development); without neurological risk (based on neurological examination, assessment of spontaneous movements, or neuroimaging findings); with no prior surgical interventions; with no hospitalizations longer than 5 days; and with no congenital malformations of the head or musculoskeletal system
Epistemonikos ID: 0d35f7e050a4162c0cf2017da37fecffb121073f
First added on: Oct 08, 2026