Randomized Controlled Trial Protocol on the Effects of a Sensory Motor Intervention Associated with Kangaroo Skin-to-Skin Contact in Preterm Newborns

Abstract

There is still very limited evidence on the effects of neonatal interventions on infant neurodevelopmental outcomes, including general movements (GMs). This research will primarily assess the effects of a sensory motor physical therapy intervention combined with kangaroo skin-to-skin contact on the GMs of hospitalized preterm newborns. Secondary outcomes include body weight, posture and muscle tone, behavioral state, length of hospital stay, and breastfeeding. This study protocol details a two-arm parallel clinical trial methodology, involving participants with a postmenstrual age of 34-35 weeks admitted to a Neonatal Intermediate Care Unit (NInCU) with poor repertoire GMs. Thirty-four participants will be randomly assigned to either the experimental group, receiving a 10-day sensory motor physical therapy associated with kangaroo skin-to-skin contact, or the control group, which will only receive kangaroo skin-to-skin contact. The study will measure GMs (primary outcome), and body weight, posture and muscle tone, behavioral state, length of hospital stay, and breastfeeding (secondary outcomes). Data collection occurs in the NInCU before and after the intervention, with follow-up measurements post discharge at 2-4 weeks and 12-15 weeks post-term. SPSS will be used for data analyses. The results will provide novel information on how sensory motor experiences may affect early neurodevelopment and clinical variables in preterm newborns.

Keywords: early intervention; kangaroo mother care; premature birth; sensorimotor interventions.

Figure 1

Schematic depicting enrolment, interventions, and assessments (SPIRIT template). GA: gestational age; GMA: General Movement Assessment; SAB, Silverman–Andersen Bulletin; -t₁: screening period; t₁: day before the intervention (day 0); t₂–t₁₁: intervention (days 1 to 10); t₁₂: day after the intervention; t₁₃: hospital discharge; t₁₄: 2–4 weeks post-term; t₁₅: 12–15 weeks post-term. SPIRIT: Standard Protocol Items: Recommendations for Interventional Trials.

Figure 2

Flow diagram that will be used in the study. GMs: general movements, EG: experimental group, CG: control group, RR: respiratory rate, HC: heart rate, SpO2: oxygen saturation, SAB: Silverman–Andersen Bulletin, BS: behavioral state, BT: body temperature, ITT: intention-to-treat analysis.