Hypothermia Plus Melatonin in Asphyctic Newborns: A Randomized-Controlled Pilot Study.

OBJECTIVES: To investigate the effect of adding melatonin to hypothermia treatment on neurodevelopmental outcomes in asphyctic newborns. DESIGN: Pilot multicenter, randomized, controlled, double-blind clinical trial. Statistical comparison of results obtained in two intervention arms: hypothermia plus placebo and hypothermia plus melatonin. SETTING: Level 3 neonatal ICU. PATIENTS: Twenty-five newborns were recruited. INTERVENTIONS: The hypothermia plus melatonin patients received a daily dose of IV melatonin, 5 mg per kg body weight, for 3 days. General laboratory variables were measured both at neonatal ICU admission and after intervention. All infants were studied with amplitude-integrated electroencephalography and brain MRI within the first week of life. The neurodevelopmental Bayley III test, the Gross Motor Function Classification System, and the Tardieu scale were applied at the ages of 6 and 18 months. MEASUREMENTS AND MAIN RESULTS: Clinical characteristics, laboratory evaluations, MRI findings, and amplitude-integrated electroencephalography background did not differ between the treatment groups. The newborns in the hypothermia plus melatonin group achieved a significantly higher composite score for the cognitive section of the Bayley III test at 18 months old, with respect to the hypothermia plus placebo group (p = 0.05). There were no differences between the groups according to the Gross Motor Function Classification System and Tardieu motor assessment scales. CONCLUSIONS: The early addition of IV melatonin to asphyctic neonates is feasible and may improve long-term neurodevelopment. To our knowledge, this is the first clinical trial to analyze the administration of IV melatonin as an adjuvant therapy to therapeutic hypothermia.

Effects of an Exercise Intervention in Frail Older Patients with Chronic Obstructive Pulmonary Disease Hospitalized due to an Exacerbation: A Randomized Controlled Trial.

The objective of this study was to determine whether an exercise intervention using a pedal exerciser is able to reduce disability in frail older patients with chronic obstructive pulmonary disease (COPD) during hospitalization due to an acute exacerbation. This study was a randomized, single-blind clinical trial. Fifty-eight frail older patients admitted to hospital due to an acute exacerbation of COPD (AECOPD) were included in this study. All patients received standard medical and pharmacological care. Patients assigned to the intervention group also received an exercise intervention. The main outcome measures were balance, muscle strength, and exercise capacity. Significant between-group differences were found in muscle strength (p = 0.028) and balance (p = 0.013) after the intervention. All the variables improved significantly (p < 0.05) in the exercise intervention group. In the intervention group, the mean difference in muscle strength between baseline and discharge was 10.47 N. Balance also improved, showing a mean difference of 7.56 seconds on the right leg and 6.57 seconds on the left leg. Exercise capacity improved as well, with a difference of 4.97 stands between baseline and discharge. All the variables showed impairment in the control group. In conclusion, an exercise intervention using a pedal exerciser during the hospital stay of frail elderly patients with an AECOPD improves muscle strength, balance, and exercise capacity.

Repercussions of plagiocephaly on posture, muscle flexibility and balance in children aged 3-5 years old.

AIM: The objective of the study was to assess posture, muscle flexibility and balance in children aged 3-5 years old with a history of nonsynostotic plagiocephaly. METHODS: Fifty-two children with previous history of plagiocephaly were evaluated, along with 52 control subjects matched for age, sex, height, weight and physical activity. The outcome measures included static posture, assessed through the measurement of angles and distances between anatomical landmarks; muscle flexibility, evaluated with the Stibor, Shober and finger-to-floor distance tests and balance, assessed by the Pediatric Balance Scale. RESULTS: One-way analysis of variance afforded statistically significant differences (P < 0.05) in head position, muscle flexibility (thoracic mobility and trunk and lower limbs muscle shortening) and balance. CONCLUSION: Children with previous history of non-synostotic plagiocephaly present changes in head position, muscle shortening and a poor balance when compared to control children at 3-5 years old.

Impact of torticollis associated with plagiocephaly on infants' motor development.

OBJECTIVE: This study investigated whether torticollis (congenital or acquired) in infants with plagiocephaly affects the achievement of specific gross motor milestones. METHODS: A total of 175 infants affected by plagiocephaly with or without torticollis were recruited and included in this prospective trial. Anthropometric and clinical variables were recorded at baseline. The infants were included in a physiotherapy treatment program, and they were monthly assessed until hospital discharge. RESULTS: Significant differences (P < 0.05) were observed in the achievement of rolling over, crawling, and standing skills depending on the specific profile (plagiocephaly and plagiocephaly with congenital or acquired torticollis). After adjusting for the severity of the plagiocephaly and the age at referral, the torticollis was significantly (P < 0.05) associated with crawling and standing skills. CONCLUSIONS: The findings suggest that the presence or absence of congenital or acquired torticollis is an important factor that affects gross motor development in infants with plagiocephaly.

Feelings of loss in parents of children with infantile cerebral palsy.

BACKGROUND: Raising a child diagnosed with infantile cerebral palsy is a challenge for families and causes many changes in their lifestyle. When the diagnosis is unexpected, feelings related to loss and hard-to-manage emotions such as uncertainty and bewilderment can arise. OBJECTIVE: To identify how feelings of loss are structured in fathers and mothers of children diagnosed with infantile cerebral palsy. METHODS: A qualitative design with based on a grounded theory approach was used. Twenty-four participants were selected to participate in the research from San Cecilio Clinical Hospital in the city of Granada (Spain). The sampling procedure was purposive based on inclusion and exclusion criteria and ended when data saturation was acquired. The participants were interviewed according to a script developed ad hoc. Data were collected during 2012. The interviews were analyzed with Atlas.ti 6.2 software, using the sequence suggested by Straus and Corbin including open, axial and selective codification. RESULTS: The analysis led to the identification of the main category, "Experiences of loss." The codes contributing to explain these experiences were "Shock," "Hope," "Traumatic Experience," "Feelings related to loss," "Ideal Child" and "Acceptance of the Child." CONCLUSIONS: These parents experience feelings of loss of the ideal child, which are more complex in the first stage of the diagnosis and when the severity of the cerebral palsy is greater. Emotional intervention on the part of health care providers is needed to aid parents in facing the various obstacles encountered throughout their child's up-bringing.