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Effects of therapeutic hammock in hospitalized preterm newborns

Effects of positioning hammock on the neurodevelopment and clinical outputs of preterm infants: randomized controlled clinical trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
REBEC
Registry ID
RBR-2ys36cq
Enrollment
Unknown
Registered
2021-05-13
Start date
2021-03-01
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

Premature birth

Interventions

E02.779
Experimental group: 17 human newborns, with a corrected gestational age of 34 to 36 weeks, will be placed in a hammock fixed to the hospital bed (crib / incubator) for 45-60 minutes, for 10 consecutiv
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Sponsors

Universidade Federal de Mato Grosso do Sul (UFMS)
Lead Sponsor
Universidade Federal de Mato Grosso do Sul (UFMS)
Collaborator

Eligibility

Age
34 Weeks to 36 Weeks

Inclusion criteria

Inclusion criteria: Preterm infants with corrected gestational age equal to 34 weeks; with more than 72 hours of postnatal life; hospitalized in a neonatal unit, with a stable clinical condition; with generalized movements of poor repertoire characteristic; without the need for invasive or noninvasive mechanical ventilation;

Exclusion criteria

Exclusion criteria: Those with congenital malformations, degree 3 and 4 periintraventricular hemorrhage, osteomyoarticular disorders, use of central nervous system depressants and use of invasive or noninvasive mechanical ventilation will not be included. The study will use analysis by intention to treat, that is, all participants included will be considered. However, only those whose parents request the removal of the infant from the study will be excluded.

Design outcomes

Primary

MeasureTime frame
Optimization of the weight gain, measured through digital scale, considered by the observation of an increase of at least 10% in pre and post-intervention measurements; and improvement of general movements quality, verified through the method of Prechtl's General Movements Assessment, with increased number of general movements cathegorized as normal (difference of at least 5% between groups).

Secondary

MeasureTime frame
Differences between the groups regarding physiological parameters will be analyzed (peripheral oxygen saturation, respiratory rate, heart rate and body temperature), behavioral status, length of stay and weight gain. For the length of hospital stay, verified by adding the number of days spent in the hospital environment, the decrease will be considered as a reduction of at least 5% in the number of days of hospitalization when comparing the groups. Increase in weight gain, measured using a digital scale, based on an increase of at least 10% in the pre and post-intervention measurements For the verification of peripheral oxygen saturation, normal levels will be considered between 92 and 99%, In the assessment of respiratory rate, the levels of normality for the age group of the study public are between 25 and 50 breaths per minute. Regarding heart rate, normal values ??will be considered in the range of 120-170 beats per minute. For body temperature, temperatures between 36.5 - 37.5 oC will be allowed. For these physiological parameters, a 5% decrease or increase in pre- and post-intervention measurements will be considered relevant when comparing the groups. The behavioral state will be assessed using the Neonatal Behavioral Assessment Scale (NBAS) and the score ranges from 1 to 6 points, which considers: 1) Deep sleep; 2) Light sleep; 3) Drowsiness; 4) Awake, alert; 5) Active alert and 6) Crying. Through this score the groups will be compared, in pre and post intervention moments.

Countries

Brazil

Contacts

Public ContactDaniele Marangoni
daniele.soares@ufms.br+55(67)991635949

Outcome results

None listed

Source: REBEC (via WHO ICTRP)