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RAPIDIRON Trial follow-up study - the RAPIDIRON-KIDS Study: protocol of a prospective observational follow-up study.
Derman, RJ, Bellad, RB, Bellad, MB, Bradford-Rogers, J, Georgieff, MK, Aghai, ZH, Thind, S, Auerbach, M, Boelig, R, Leiby, BE, et al
Trials. 2023;(1):818
Abstract
BACKGROUND Anemia is a worldwide problem with iron deficiency being the most common cause. When anemia occurs in pregnancy, it increases the risk of adverse maternal, fetal, and postnatal outcomes. It induces preterm births and low birth weight (LBW) deliveries, long-term neurodevelopmental sequelae, and an increased risk of earlier onset of postnatal iron deficiency. Anemia rates are among the highest in South Asia, and India's National Family Health Survey (NFHS-5) for 2019-2021 indicated that over half of pregnant women, and more than 65% of children, in the country are classified as anemic (Sciences IIfP, National Family Health Survey-5, 2019-21, India Fact Sheet). In 2021, the parent RAPIDIRON Trial (Derman et al., Trials 22:649, 2021) was initiated in two states in India, with the goal of assessing whether a dose of intravenous (IV) iron given to anemic women during early pregnancy results in a greater proportion of participants with normal hemoglobin concentrations in the third trimester and a lower proportion of participants with LBW deliveries compared to oral iron. As a follow-up to the RAPIDIRON Trial, the RAPIDIRON-KIDS Study will follow the offspring of previously randomized mothers to assess, neurobehavioral, hematological, and health outcomes. METHODS This prospective observational cohort study will follow a subset of participants previously randomized as part of the RAPIDIRON Trial and their newborns. Study visits occur at birth, 6 weeks, 4 months, 12 months, 24 months, and 36 months and include blood sample collection with both maternal and infant participants and specific neurobehavioral assessments conducted with the infants (depending on the study visit). The primary outcomes of interest are (1) infant iron status as indicated by both hemoglobin and ferritin (a) at birth and (b) at 4 months of age and (2) the developmental quotient (DQ) for the cognitive domain of the Bayley Scales of Infant Development Version IV (BSID-IV) at 24 months of age. DISCUSSION This RAPIDIRON-KIDS Study builds upon its parent RAPIDIRON Trial by following a subset of the previously randomized participants and their offspring through the first 3 years of life to assess neurodevelopmental and neurobehavioral (infants, children), hematological, and health outcomes. TRIAL REGISTRATION ClinicalTrials.gov NCT05504863 , Registered on 17 August 2022. Clinical Trials Registry - India CTRI/2022/05/042933 . Registered on 31 May 2022.
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Superpulsed laser irradiation increases osteoblast activity via modulation of bone morphogenetic factors.
Saracino, S, Mozzati, M, Martinasso, G, Pol, R, Canuto, RA, Muzio, G
Lasers in surgery and medicine. 2009;(4):298-304
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Abstract
BACKGROUND AND OBJECTIVE Laser therapy is a new approach applicable in different medical fields when bone loss occurs, including orthopedics and dentistry. It has also been used to induce soft-tissue healing, for pain relief, bone, and nerve regeneration. With regard to bone synthesis, laser exposure has been shown to increase osteoblast activity and decrease osteoclast number, by inducing alkaline phosphatase (ALP), osteopontin, and bone sialoprotein expression. Studies have investigated the effects of continuous or pulsed laser irradiation, but no data are yet available on the properties of superpulsed laser irradiation. This study thus aimed to investigate the effect of superpulsed laser irradiation on osteogenic activity of human osteoblast-like cells, paying particular attention to investigating the molecular mechanisms underlying the effects of this type of laser radiation. STUDY DESIGN/MATERIALS AND METHODS Human osteoblast-like MG-63 cells were exposed to 3, 7, or 10 superpulsed laser irradiation (pulse width 200 nanoseconds, minimum peak power 45 W, frequency 30 kHz, total energy 60 J, exposure time 5 minutes). The following parameters were evaluated: cell growth and viability (light microscopy, lactate dehydrogenase release), calcium deposits (Alizarin Red S staining), expression of bone morphogenetic factors (real-time PCR). RESULTS Superpulsed laser irradiation decreases cell growth, induces expression of TGF-beta2, BMP-4, and BMP-7, type I collagen, ALP, and osteocalcin, and increases the size and the number of calcium deposits. The stimulatory effect is maximum on day 10, that is, after seven applications. CONCLUSIONS Reported results show that superpulsed laser irradiation, like the continuous and pulsed counterparts, possesses osteogenic properties, inducing the expression of molecules known to be important mediators of bone formation and, as a consequence, increasing calcium deposits in human MG-63 cells. Moreover, the data suggest a new potential role for PPARgamma as a regulator of osteoblast proliferation.
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Effect of superpulsed laser irradiation on bone formation in a human osteoblast-like cell line.
Martinasso, G, Mozzati, M, Pol, R, Canuto, RA, Muzio, G
Minerva stomatologica. 2007;(1-2):27-30
Abstract
AIM: The effect superpulsed of low-level laser therapy (SLLLT) on bone regeneration has been the focus of recent research. This preliminary study investigated the effect of superpulsed laser irradiation on proliferation and bone formation in human osteoblast-like cells MG-63. METHODS Human osteoblast-like cells MG-63 were exposed every 24 h to superpulsed low-level laser produced by the device Lumix 2 HFPL Dental (Fisioline s.n.c., Verduno, Cuneo, Italy); the experimental protocol comprised 4 days of treatment. At each experimental time, cell proliferation and some markers of osteoblast activity were evaluated. RESULTS Numbers of laser-treated cells increased starting from day 2 of treatment. The ability of SLLLT irradiation to stimulate bone production was evaluated by determining the expression of osteocalcin and alkaline phosphatase, proteins involved in calcium nodule formation. These proteins increased markedly after 3 days of laser treatment. CONCLUSIONS These preliminary results show that repeated SLLLT irradiation stimulates cell proliferation in human osteoblast-like cells and, importantly, increases the expression of proteins essential for bone formation.