Skip to content

Elastic Swaddling and General Movements

Comparison of Swaddling-type positioning with elastic tissue and inelastic tissue in the movement of preterm newborns: randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-285x2pv
Enrollment
Unknown
Registered
2022-10-26
Start date
2022-04-05
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle tonus

Interventions

In the intervention group, newborns will be positioned in swaddling with elastic fabric, for three continuous hours between 12:00 and 15:00 h (quietest time in the unit, all participants already fed a

Sponsors

Micheli Bernardone Saquetto
Lead Sponsor
Hospital Inácia Pinto dos Santos
Collaborator

Eligibility

Age
28 Weeks to 37 Weeks

Inclusion criteria

Inclusion criteria: Preterm newborns admitted to the neonatal intensive care unit, with a gestational age of less than 37 weeks; lifetime greater than or equal to 72 hours;

Exclusion criteria

Exclusion criteria: premature newborns using phototherapy; birth defects; peri-intraventricular hemorrhage greater than Grade II (two); diet every two hours; use of chest tube; unstable hemodynamics; risk of hip dislocation; postoperative period of thoracic and abdominal surgeries; mother with a history of illicit drug and alcohol use during pregnancy;

Design outcomes

Primary

MeasureTime frame
the main expected outcome is Spontaneous movement, will be evaluated by Pretchl's assessment of general movements method, which evaluates the general movements of preterm newborns up to five months of corrected gestational age. Spontaneous generalized movements can be defined as normal (varies with age) as (1) Writhing Movements (up to 8th week post term) and (2) Fidgety Movement (9th to 20th week post term). Abnormal movements are classified as (1) Poor repertoire - the sequence of successive components of the movement is monotonous, the amplitude, speed and intensity lack normal variability, (2) Cramped-synchronised - rigid movements with contraction and relaxation occurring simultaneously, ( 3) Chaotic - large amplitude movements occur in a chaotic order without any fluency, (4) Abnormal Fidgety Movements - look like normal irregular movements, but their amplitude, speed and jolts are moderately or very exaggerated and (5) Absence of Fidgety Movements - Irregular movements are never observed from 9 to 20 weeks post term, we call this abnormality “absence of Fidgety Movements”. The baby will be filmed in the supine position using a diaper. The recording duration depends on the age of the child. To collect approximately three General Movements for reliable judgment, we usually record premature babies for 30 to 60 minutes, regardless of whether the baby is asleep or awake. This recording does not require the observer to be present during the recording or the further evaluation of the entire recording. Afterwards, this recording is reviewed and approximately three General Movement sequences are copied to the evaluation file. From the age of term, 5 to 10 minutes of recording is usually sufficient. Recordings of a baby fussing or crying cannot be analyzed (Einspieler et al., 1997). Therefore, in this study the babies will be filmed once a week until they reach the corrected age of 40 weeks and at two, three and five months of corrected gestational age. The assessment

Secondary

MeasureTime frame
1. States of consciousness will be evaluated during the interventions, through the states of consciousness of the Brazelton Scale of 1973. The behavioral states aim to assess the quality of each state, variability, stability, transitions and dominant state. These are defined as: state 1 – deep sleep, characterized by eyes tightly closed, deep and regular breathing, with almost no motor activity, with occasional small jumps separated by long intervals; State 2 – Active sleep (REM – rapid eyes movement) characterized by eyes closed, but with occasional movements, breathing is irregular and faster, grimaces, smiles, presents mouth and suction movements, and body movements ranging from small contractions to brief bouts of writhing and stretching; State 3 – drowsiness, eyes open and closed, and may be more open, but with a drowsy appearance and may perform smooth movements of arms and legs; State 4 – alert inactive, the body and face are relatively inactive, with bright eyes and regular breathing; State 5 active alert, eyes are still open but with greater body activity and may whimper; and State 06 – crying, presents strong crying and manifestation of great discomfort (BRASIL, 2011; BM, EZ, & TB, 2004). The states of consciousness will be collected 10 minutes before performing the positioning and every 30 minutes during the intervention and after 30 minutes of the intervention. During and after positioning, adverse effects such as loss of venous access, difficulty in monitoring, episodes of vomiting, apnea and signs of hemodynamic and respiratory instability will be evaluated.;2. Flexor tone, will be evaluated using the HNNE - Hammersmith Neonatal Neurological Assessment. This assessment was validated for low-risk term newborns and preterm newborns when they reach term age, and can be applied in a modified form in babies who need ventilatory support. It establishes the variability of items at different gestational ages and which findings are most common at each age. It i

Countries

Brazil

Contacts

Public ContactMicheli Saquetto

Universidade Federal da Bahia

msaquetto@ufba.br+55 (71) 3283-8900

Outcome results

None listed

Source: REBEC (via WHO ICTRP)