Effect of Kangaroo Position on microcirculation of preterm newborns: a controlled randomized clinical trial.
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ABSTRACT: Objective
The objective of this study was to evaluate the effect of Kangaroo Position (KP) in microcirculation (MC) of the flexor muscles of preterm newborns.Method
A controlled clinical trial was conducted in the city of Recife, Brazil, with 26 preterm children randomized in the Kangaroo Group (13) and in the Control Group (13). Assessments of blood flow, temperature, and tissue oxygen saturation (SO2) were made at two different times and in the biceps brachii muscle and hamstrings muscle group: before the KP and after 24 h of KP. In the Control Group, the registrations were performed at the times corresponding to those of the Kangaroo Group. The mean values among the times were analyzed by paired t-test for repeated measures. The clinical trial was recorded in Clinical Trials (NCT03611088).Results
In the Kangaroo Group there was an increase in tissue temperature and blood flow at the time evaluation periods (p < 0.05). In the control group, there was no statistical difference between the recording moments hamstring muscles group, but in the biceps brachii, there was a reduction in mean blood flow (p = 0.023).Conclusion
In conclusion, the KP has effects on the microcirculation of the flexor muscles of preterm newborns.
SUBMITTER: Miranda RM
PROVIDER: S-EPMC9432287 | biostudies-literature | 2022 Mar-Apr
REPOSITORIES: biostudies-literature
Publications
Effect of Kangaroo Position on microcirculation of preterm newborns: a controlled randomized clinical trial.
Miranda Rafael Moura RM Cabral Filho José Eulálio JE Diniz Kaísa Trovão KT Clough Geraldine Frances GF Alves João Guilherme Bezerra JGB Lima Geisy Maria Souza GMS Figueredo Natália Priscila Dos Santos NPDS França Ariane Amarali de AA Luna Júlia Thalita Barbosa JTB
Jornal de pediatria 20210826 2
<h4>Objective</h4>The objective of this study was to evaluate the effect of Kangaroo Position (KP) in microcirculation (MC) of the flexor muscles of preterm newborns.<h4>Method</h4>A controlled clinical trial was conducted in the city of Recife, Brazil, with 26 preterm children randomized in the Kangaroo Group (13) and in the Control Group (13). Assessments of blood flow, temperature, and tissue oxygen saturation (SO<sub>2</sub>) were made at two different times and in the biceps brachii muscle ...[more]
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Project description:ObjectiveTo compare the electromyographic activity of preterm newborns placed in the kangaroo position with the activity of newborns not placed in this position.DesignA cohort study.SettingA Kangaroo Unit sector and a Nursery sector in a secondary and tertiary care at a mother-child hospital in Recife, Brazil.ParticipantsPreterm infants of gestational age 27-34 weeks (n=38) and term infants (n=39).Primary and secondary outcome measuresSurface electromyography was used to investigate muscle activity in the brachial biceps at rest. 3 groups were designed: (1) preterm newborns in the kangaroo position (PT-KAN), where the newborn remains in a vertical position, lying face down, with limbs flexed, dressed in light clothes, maintaining skin-to-skin contact with the adult's thorax. Her electromyographic activity was recorded at 0 h (immediately before starting this position), and then at 48 h after the beginning of the position (but newborns were kept in the kangaroo position for 8-12 h per day) and at term equivalent age (40±1 weeks); (2) preterm newborns not in the kangaroo position (PT-NKAN), in which measurements were made at 0 h and 48 h; and (3) term newborns (T), in which measurements were made at 24 h of chronological age.ResultsThe Root Mean Square (RMS) values showed significant differences among groups (F(5,108)=56.69; p<0.001). The multiple comparisons showed that RMS was greater at 48 h compared to 0 h in the preterm group in the kangaroo position, but not in the group not submitted in the kangaroo position. The RMS in the term equivalent aged group in the kangaroo position was also greater when compared with those in the term group.ConclusionsThe kangaroo position increases electromyographic activity in the brachial biceps of preterm newborns and those who have reached the age equivalent to term.
| S-EPMC4212184 | biostudies-literature
Project description:ObjectiveTo verify the short-term influence of the kangaroo position (KP) on the electromyography activity of preterm newborns.MethodA clinical study was conducted in a kangaroo unit sector (secondary and tertiary care) in the city of Recife, Brazil, with 44 preterm infants randomized to intervention (n=21) and control (n=23) groups. The KP was performed through a band that supports the newborn against the adult's thorax, in a prone and vertical position, and infants were dressed with few pieces of clothes, thus keeping skin-to-skin contact with the mother. Surface electromyography was used to investigate the muscle activity of the biceps brachii and hamstrings. The randomization of the groups was performed by the program R® (v. 3.3.1). The electromyography registrations were made at three different times: before the KP and after one and two hours of KP. In the control group, the registrations were performed at the times corresponding to those of the intervention group. The mean values of the electromyography activity among the times were analyzed by ANOVA for repeated measures and the Kruskal-Wallis test. The clinical trial was recorded in ClinicalTrials.gov (NCT02849665 - 07/28/2016).ResultsIn the intervention group (n=21), there was a variation of the electromyography activity values between the three recording moments for both the biceps brachii and hamstrings. In the control group (n=23), there was no statistical difference between the recording moments for both.ConclusionsThe KP increases the short-term electromyographic activity of the biceps brachii and hamstrings.
| S-EPMC9432240 | biostudies-literature
Project description:ImportancePreterm newborns at risk of respiratory distress syndrome are supported with continuous positive airway pressure (CPAP). Many newborns worsen despite CPAP and are intubated for surfactant administration, an effective therapy for treatment of respiratory distress syndrome. Endotracheal intubation is associated with adverse effects. Pharyngeal administration of surfactant to preterm animals and humans has been reported as an alternative.ObjectiveTo assess whether giving prophylactic oropharyngeal surfactant to preterm newborns at birth would reduce the rate of intubation for respiratory failure.Design, setting, and participantsThis unblinded, parallel-group randomized clinical trial (Prophylactic Oropharyngeal Surfactant for Preterm Infants [POPART]) was conducted from December 17, 2017, to September 11, 2020, at 9 tertiary neonatal intensive care units in 6 European countries. Newborns born before 29 weeks of gestation without severe congenital anomalies, for whom intensive care was planned, were eligible for inclusion. The data were analyzed from July 27, 2022, to June 20, 2023.InterventionNewborns were randomly assigned to receive oropharyngeal surfactant at birth in addition to CPAP or CPAP alone. Randomization was stratified by center and gestational age (GA).Main outcomes and measuresThe primary outcome was intubation in the delivery room for bradycardia and/or apnea or in the neonatal intensive care unit for prespecified respiratory failure criteria within 120 hours of birth. Caregivers were not masked to group assignment.ResultsAmong 251 participants (mean [SD] GA, 26 [1.5] weeks) who were well matched at study entry, 126 (69 [54.8%] male) with a mean (SD) birth weight of 858 (261) grams were assigned to the oropharyngeal surfactant group, and 125 (63 [50.4%] male) with a mean (SD) birth weight of 829 (253) grams were assigned to the control group. The proportion of newborns intubated within 120 hours was not different between the groups (80 [63.5%) in the oropharyngeal surfactant group and 81 [64.8%] in the control group; relative risk, 0.98 [95% CI, 0.81-1.18]). More newborns assigned to the oropharyngeal surfactant group were diagnosed with and treated for pneumothorax (21 [16.6%] vs 8 [6.4%]; P = .04).Conclusions and relevanceThis randomized clinical trial found that administration of prophylactic oropharyngeal surfactant to newborns born before 29 weeks' GA did not reduce the rate of intubation in the first 120 hours of life. These findings suggest that administration of surfactant into the oropharynx immediately after birth in addition to CPAP should not be routinely used.Trial registrationEudraCT: 2016-004198-41.
| S-EPMC10714282 | biostudies-literature
Project description:BackgroundPreterm infants have a low level of bone mineralization compared to those born at term, since 80% of calcium incorporation occurs at the end of pregnancy. The purpose of the present study was to investigate the effect of reflex locomotion therapy on bone modeling and growth in preterm infants and to compare its effect with those of other Physiotherapy modalities.MethodsA multicentre randomized controlled clinical trial was conducted (02/2016 - 07/2020). 106 preterm infants born at the Virgen de la Arrixaca University Clinical Hospital, the General University Hospital of Elche and the Torrecárdenas University Hospital of Almería, between 26 and 34 weeks with hemodynamic stability, complete enteral nutrition and without any metabolic, congenital, genetic, neurological or respiratory disorders were evaluated for inclusion. Infants were randomly assigned to three groups: one group received reflex locomotion therapy (EGrlt); another group received passive mobilizations with gentle joint compression (EGpmc); and the control group received massage (CG). All treatments were carried out in the neonatal units lasting one month. The main outcome measure was bone formation and resorption measured with bone biomarkers. A mixed ANOVA was used to compare the results of bone biomarkers, and anthropometric measurements.ResultsInfants were randomized to EGrlt (n = 38), EGpmc (n = 32), and CG (n = 36). All groups were similar in terms of gender (p = 0.891 female 47.2%), gestational age (M = 30.753, SD = 1.878, p = 0.39) and birth weight (M = 1413.45, SD = 347.36, p = 0.157). At the end of the study, significant differences were found between the groups in their interaction in bone formation, measured with osteocalcin [F (2,35) = 4.92, p = 0.013, ηp2 = 0.043], in benefit of the EGrlt.ConclusionsReflex locomotion therapy has been effective in improving bone formation, more so than other Physiotherapy modalities. Therefore, reflex locomotion therapy could be considered one of the most effective physiotherapeutic modalities for the prevention and treatment of osteopenia of prematurity.Trial registrstionTrial retrospectively registered at ClinicalTrials.gov. First posted on 22/04/2020.Registration numberNCT04356807 .
| S-EPMC9229521 | biostudies-literature
Project description:This study aims to assess the efficacy of the modified kangaroo care lateral position on the thermal stability of preterm neonates versus conventional kangaroo care prone position. A non-inferiority randomized parallel clinical trial. Kangaroo care will be performed in a lateral position for the experimental group and in a prone position for the control group preterm. The study will take place at the neonatal intensive care unit (NICU) of a University Hospital. The participants will be extremely premature infants (under 28 weeks of gestational age) along the first five days of life, hemodynamically stable, with mother or father willing to do kangaroo care and give their written consent to participate in the study. The sample size calculated was 35 participants in each group. When the premature infant is hemodynamically stable and one of the parents stays in the NICU, the patient will be randomized into two groups: an experimental group or a control group. The primary outcome is premature infant axillary temperature. Neonatal pain level and intraventricular hemorrhage are secondary outcomes. There is no scientific evidence on modified kangaroo care lateral position. Furthermore, there is little evidence of increased intraventricular hemorrhage association with the lateral head position necessary in conventional or prone kangaroo care in extremely premature newborns. Kangaroo care is a priority intervention in neonatal units increasing the time of use more and more, making postural changes necessary to optimize comfort and minimize risks with kangaroo care lateral position as an alternative to conventional prone position kangaroo care. Meanwhile, it is essential to ensure that the conventional kangaroo care prone position, which requires the head to lay sideways, is a safe position in terms of preventing intraventricular hemorrhage in the first five days of life of children under 28 weeks of gestational age. Trial registration at clinicaltrials.gov: NCT03990116.
| S-EPMC8750690 | biostudies-literature
Project description:BackgroundApnoea of prematurity (AOP) is one of the most common diagnoses among preterm infants. AOP often leads to hypoxemia and bradycardia which are associated with an increased risk of death or disability. In addition to caffeine therapy and non-invasive respiratory support, doxapram might be used to reduce hypoxemic episodes and the need for invasive mechanical ventilation in preterm infants, thereby possibly improving their long-term outcome. However, high-quality trials on doxapram are lacking. The DOXA-trial therefore aims to investigate the safety and efficacy of doxapram compared to placebo in reducing the composite outcome of death or severe disability at 18 to 24 months corrected age.MethodsThe DOXA-trial is a double blinded, multicentre, randomized, placebo-controlled trial conducted in the Netherlands, Belgium and Canada. A total of 396 preterm infants with a gestational age below 29 weeks, suffering from AOP unresponsive to non-invasive respiratory support and caffeine will be randomized to receive doxapram therapy or placebo. The primary outcome is death or severe disability, defined as cognitive delay, cerebral palsy, severe hearing loss, or bilateral blindness, at 18-24 months corrected age. Secondary outcomes are short-term neonatal morbidity, including duration of mechanical ventilation, bronchopulmonary dysplasia and necrotising enterocolitis, hospital mortality, adverse effects, pharmacokinetics and cost-effectiveness. Analysis will be on an intention-to-treat principle.DiscussionDoxapram has the potential to improve neonatal outcomes by improving respiration, but the safety concerns need to be weighed against the potential risks of invasive mechanical ventilation. It is unknown if the use of doxapram improves the long-term outcome. This forms the clinical equipoise of the current trial. This international, multicentre trial will provide the needed high-quality evidence on the efficacy and safety of doxapram in the treatment of AOP in preterm infants.Trial registrationClinicalTrials.gov NCT04430790 and EUDRACT 2019-003666-41. Prospectively registered on respectively June and January 2020.
| S-EPMC10566117 | biostudies-literature
Project description:BackgroundNeonatal mortality due to preterm birth and low birthweight remains a significant challenge in Pakistan. Kangaroo mother care (KMC) is a unique, low-cost intervention proven to reduce neonatal mortality and morbidity and increase exclusive breastfeeding rates. However, KMC has not been attempted in community settings in Pakistan. We aim to implement and evaluate the effectiveness of a community-based KMC package to reduce neonatal morbidity and mortality among preterm and low birthweight (LBW) infants, which will provide evidence for policy development and the large-scale implementation of KMC across the country.ObjectiveThe primary objective of this trial is to reduce neonatal mortality among preterm and LBW infants. The secondary objectives are growth (measured as weight gain), reduced incidence of possible serious bacterial infection, and increased exclusive breastfeeding and continued breastfeeding practices.MethodsWe designed a community-based cluster randomized controlled trial in one rural district of Pakistan. Stable, LBW babies (weighing 1200 grams to 2500 grams) are included in the study. The community KMC package, consisting of the KMC kit, information and counseling material, and community mobilization through KMC champions (village volunteers), was designed after preliminary research in the same geographical location and implemented in intervention clusters. The standard essential newborn care is offered in the control clusters. Infants are recruited and followed up by independent teams of data collectors. Data are collected on the duration of skin-to-skin contact, growth, breastfeeding practices, morbidities, neonatal mortality, and neurodevelopment status. Data analysis will be conducted based on the intention to treat principle. The Cox regression model will be used to assess the primary outcome of neonatal mortality. The secondary outcomes will be evaluated using linear or logistic regression.ResultsThe Ethics Review Committee of Aga Khan University, Pakistan, approved the study protocol in February 2017. Data collection began in August 2019 and will be completed in December 2021. Data analyses are yet to be completed.ConclusionsThis intervention may be effective in preventing sepsis and subsequently improve survival in LBW newborns in Pakistan and other low-income and middle-income countries worldwide.Trial registrationclinicaltrials.gov NCT03545204; https://clinicaltrials.gov/ct2/show/NCT03545204.International registered report identifier (irrid)DERR1-10.2196/28156.
| S-EPMC8386402 | biostudies-literature
Project description:Despite of growing evidence of the beneficial effects of placental transfusion techniques, there is no available sufficient data about their effects on vulnerable hemodynamics and myocardium of premature infants. The purpose of this work is to study ventricular functions and hemodynamics after applying different placental transfusion techniques, delayed cord clamping (DCC), cut cord milking (C-UCM), and intact cord milking (I-UCM). Sixty-four infants delivered whether by C-section or vaginal delivery were randomly assigned to undergo C-UCM (20-30 cm), I-UCM (3-4 strippings), and DCC (30-60 s). Functional echocardiography was done on day 1 and day 3 of life for 57 infants. Primary outcome variable was superior vena cava flow measurement in infants having placental transfusion in the first 24 h of life and between 64 and 72 h. Secondary outcomes were other echocardiographic and clinical hemodynamic parameters, and biventricular functions in those infants. Of a total 196 preterm infants ≤ 32 weeks delivered in the study period, from January 2021 to August 2021, 57 infants were eligible and survived till the second examination. They were randomly assigned to the three groups. Neonates randomly assigned to DCC had significantly higher superior vena cava flow and lower right ventricular systolic function in the first 24 h of life. This finding vanished at day 3. Neonates undergone different methods of placental transfusions had similar hemoglobin, admission temperature, and mean blood pressure in the first 24 h of life.ConclusionDespite their potential benefits, placental transfusions have shown to alter the hemodynamics and adversely affect myocardial function of premature neonates.Trial registrationThis trial was registered in the clinical trial gov NCT04811872.What is known• Placental transfusion techniques might have benefits regarding prematurity- related morbidities and mortality.What is new• Placental transfusion might adversely affect the myocardium and alter hemodynamics in premature infants.
| S-EPMC9649456 | biostudies-literature
Project description:BackgroundPrevention of neurodevelopmental impairment due to preterm birth is a major health challenge. Despite advanced obstetric and neonatal care, to date there are few neuroprotective molecules available. Melatonin has been shown to have anti-oxidant/anti-inflammatory effects and to reduce brain damage, mainly after hypoxic ischemic encephalopathy. The planned study will be the first aiming to evaluate the capacity of melatonin to mitigate brain impairment due to premature birth.MethodIn our planned prospective, multicenter, double-blind, randomized vs placebo study, we will recruit, within 96 h of birth, 60 preterm newborns with a gestational age ≤ 29 weeks + 6 days; these infants will be randomly allocated to oral melatonin, 3 mg/kg/day, or placebo for 15 days. After the administration period, we will measure plasma levels of malondialdehyde, a lipid peroxidation product considered an early biological marker of melatonin treatment efficacy (primary outcome). At term-equivalent age, we will evaluate neurological status (through cerebral ultrasound, cerebral magnetic resonance imaging, vision and hearing evaluations, clinical neurological assessment, and screening for retinopathy of prematurity) as well as the incidence of bronchodysplasia and sepsis. We will also monitor neurodevelopmental outcome during the first 24 months of corrected age (using the modified Fagan Test of Infant Intelligence at 4-6 months and standardized neurological and developmental assessments at 24 months).DiscussionPreterm birth survivors often present long-term neurodevelopmental sequelae, such as motor, learning, social-behavioral, and communication problems. We aim to assess the role of melatonin as a neuroprotectant during the first weeks of extrauterine life, when preterm infants are unable to produce it spontaneously. This approach is based on the supposition that its anti-oxidant mechanism could be useful in preventing neurodevelopmental impairment. Considering the short- and long-term morbidities related to preterm birth, and the financial and social costs of the care of preterm infants, both at birth and over time, we suggest that melatonin administration could lead to considerable saving of resources. This would be the first study addressing the role of melatonin in very low birth weight preterm newborns, and it could provide a basis for further studies on melatonin as a neuroprotection strategy in this vulnerable population.Trial registrationClinicalTrials.gov NCT04235673 . Prospectively registered on 22 January 2020.
| S-EPMC7820522 | biostudies-literature
Project description:BACKGROUND:Pasteurized donor human milk (DHM) use for healthy newborns is increasing; however, no studies have explored its effect on breastfeeding outcomes. PATIENTS AND METHODS:We enrolled 60 healthy, term breastfeeding newborns with ≥4.5% weight loss in the first 36 hours in a randomized controlled trial. Thirty newborns were randomly assigned to early limited-volume DHM supplementation and 30 newborns to exclusive breastfeeding. Mothers were surveyed at 1 week and 1, 2, and 3 months regarding the mode of infant feeding. Comparing infants randomized to DHM supplementation with those exclusively breastfeeding, there was no significant difference in the proportion using formula at 1 week (21% vs 7%, P = .15), nor in the proportion of any breastfeeding (79% vs 90%, P = .30) or breastfeeding without formula at 3 months (62% vs 77%, P = .27). Conclusion For newborns with ≥4.5% weight loss in the first 36 hours, early limited-volume supplementation with DHM is unlikely to have a significant favorable impact on breastfeeding outcomes.
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