Effect of Formula Supplementation in the Hospital on the Duration of Breast-Feeding: A Controlled Clinical Trial

PEDIATRICS ◽  
1985 ◽  
Vol 75 (3) ◽  
pp. 514-518
Author(s):  
Katherine Gray-Donald ◽  
Michael S. Kramer ◽  
Susan Munday ◽  
Denis G. Leduc
Keyword(s):  
Clinical Trial ◽  
Breast Feeding ◽  
Observational Studies ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Trial Period ◽  
Feeding Rates ◽  
Early Discontinuation ◽  
Restricted Group ◽  
Breast Fed

To avoid methodologic pitfalls in previous observational studies linking formula supplementation in the hospital to early discontinuation of breast-feeding, a controlled clinical trial of restricted supplementation was conducted. In a pretrial sample of 621 newborns, a comparison of two "well-baby" nurseries found no differences in either hospital supplementation practices or the proportion of infants still being breast-fed at 4 or 9 weeks postpartum. Restriction of supplementation in one of the nurseries for the trial period (n = 781) did not result in higher breast-feeding rates at 4 or 9 weeks. There was, however, a slightly greater mean percent of birth weight lost in the restricted group (6.0% v 5.1%; P < .001). In examining the control group for evidence of an "observational" association, it was found that infants still breast-feeding at 4 or 9 weeks were far more likely to have been unsupplemented than those no longer being breast-fed. It thus appears that formula supplementation in the hospital is a marker, rather than a cause, of breast-feeding difficulty.

Breast-Feeding Rates Among Black Urban Low-Income Women: Effect of Prenatal Education

PEDIATRICS ◽  
1990 ◽  
Vol 86 (5) ◽  
pp. 741-746 ◽  
Author(s):  
Naomi Kistin ◽  
Dessa Benton ◽  
Sita Rao ◽  
Myrtis Sullivan
Keyword(s):  
Breast Feeding ◽  
Low Income ◽  
Study Groups ◽  
The United States ◽  
Control Group ◽  
Feeding Rates ◽  
Prenatal Education ◽  
Breast Feed ◽  
Low Income Women ◽  
Breast Fed

Many factors are associated with low breast-feeding rates among black low-income women. This study examines whether, despite such factors, health professionals' prenatal education of black poor women is assoicated with increased breast-feeding rates. Black women born in the United States who attended a midwives prenatal clinic (N = 159) were randomly assigned to two types of prenatal education or were followed up in a control group. All women were interviewed on entry into the study and after delivery of their infants. Women assigned to group classes attended at least one session discussing myths, problems, and benefits of breast-feeding. Women assigned to individual prenatal counseling spoke with a pediatrician or nurse practitioner, who discussed breast-feeding topics similar to those covered in the classes. Women in the control group received no additional prenatal education. The three study groups had significantly different percentages of women who breast-fed (controls 22%, classes 46%, individual sessions 53%). Higher percentages of women in the study groups carried out their prenatal plans to breast-feed (controls 50%, classes 86%, individual sessions 62%) or breast-fed despite prenatal plans to bottle-feed (controls 10%, classes 26%, individual sessions 48%). After multivariable analysis controlling for age, prenatal pians to breast-feed, prior breast-feeding experience, perceived support for breast-feeding, education, gravidity, and employment plans, women in intervention groups had a higher likelihood of breast-feeding than control subjects. These findings suggest that an increase in relatively simple, not-too-time-consuming educational efforts in institutions and offices serving black low-income women might yield significant narrowing of the gap in breast-feeding rates between white affluent women and black low-income women.

scholarly journals The control of pain due to dentin hypersensitivity in individuals with molar–incisor hypomineralisation: a protocol for a randomised controlled clinical trial

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e044653
Author(s):  
Ana Paula Taboada Sobral ◽  
Elaine Marcilio Santos ◽  
Ana Cecilia Aranha ◽  
Paulo Vinícius Soares ◽  
Caroline Moraes Moriyama ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Tooth Enamel ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Dentin Hypersensitivity ◽  
Molar Incisor Hypomineralisation ◽  
Randomised Controlled Clinical Trial ◽  
Sensitive Teeth ◽  
Randomised Controlled ◽  
Incisor Hypomineralisation

IntroductionDentin hypersensitivity (DH) is defined as high sensitivity of the vital dentin when exposed to thermal, chemical or tactile stimuli. Two mechanisms are required for the occurrence of DH: (1) the dentin must be exposed and (2) the dentinal tubules must be open and connected to the pulp. Molar–incisor hypomineralisation (MIH) is a qualitative abnormality of a genetic origin that affects tooth enamel and, in most cases, is accompanied by DH. The control of tooth sensitivity is fundamental to the successful treatment of MIH. The aim of the proposed randomised, controlled, clinical trial is to evaluate the effectiveness of different protocols for the control of DH in patients with teeth affected by MIH.Methods and analysisOne hundred and forty patients who meet the inclusion criteria will be allocated to four groups. Group 1 will be the control group (placebo). In Group 2, sensitive teeth will be sealed with PermaSeal (Ultradent). In Group 3, sensitive teeth will receive low-level laser (LLL, AsGaAl) at a wavelength of 780 nm (Laser XT Therapy, DMC, São Carlos, Brazil). In Group 4, sensitive teeth will be treated with both LLL and PermaSeal (Ultradent). DH will be evaluated 15 min after the application of the treatments and the patients will be reevaluated 1 week, 1 month, 3 months and 6 months after the treatments. The primary outcome of this study is change in pain/sensitivity, when evaluated through a Visual Analogue Scale, to determine the effectiveness of the proposed treatments, as well as differences among the evaluation times for each proposed treatment.Ethics and disseminationThis protocol has been ethically approved by the local medical ethical committee (protocol number: 4.020.261). Results will be submitted to international peer-reviewed journals and presented at international conferences.Trial registration numberNCT04407702.

scholarly journals The effect of oat bran consumption on gestational diabetes: a randomized controlled clinical trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Zahra Barati ◽  
Mina Iravani ◽  
Majid Karandish ◽  
Mohammad Hosein Haghighizadeh ◽  
Sara Masihi
Keyword(s):  
Clinical Trial ◽  
Blood Glucose ◽  
Gestational Diabetes ◽  
Fasting Blood Glucose ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Standard Diet ◽  
Oat Bran ◽  
Significant Difference

Abstract Background Gestational diabetes is the most common medical complication in pregnancy, and it has many side effects for the mother and the fetus. The aim of this study was to evaluate the effect of oat bran consumption on gestational diabetes. Methods This study is a randomized clinical trial that was performed on 112 women with gestational diabetes treated with diet. Participants were randomly divided into two groups of 56. Participants in both groups were given a diet for gestational diabetes. In addition to the diet, the intervention group received 30 g of oat bran daily for 4 weeks at lunch and dinner. Tests of fasting blood glucose and two-hour postprandial (2hpp) glucose were taken from both groups: before the intervention, and 2 and 4 weeks after the start of the intervention. Data analysis was performed using SPSS statistical software (version 22) using independent t-test, as well as Chi-square and Mann-Whitney tests. P values less than 0.05 were considered statistically significant. Results There was no statistically significant difference between the two groups in terms of mean blood glucose before the intervention, while 2 and 4 weeks after the intervention, mean fasting blood glucose and two-hour postprandial (2hpp) glucose decreased significantly in the intervention group compared with the control group (P < 0.001). Conclusion Based on the results of this study, the addition of oat bran to the standard diet for pregnant women with gestational diabetes reduced fasting blood glucose and two-hour postprandial (2hpp) glucose. More detailed studies with higher sample sizes are recommended to prove the effectiveness of this valuable dietary supplement. Trial registration IRCT registration number:IRCT20191220045828N1. Registration date: 2020-04-18. Registered while recruiting.

scholarly journals Faulty Breast Feeding Practice : A Risk Factor in Malnourished Children

2015 ◽  
Vol 14 (2) ◽  
pp. 43-47
Author(s):  
Sukhendu Shekhar Sen ◽  
Jhulan Das Sharma ◽  
Dhananjoy Das ◽  
Shahed Iqbal ◽  
Md Badruddoza
Keyword(s):  
Breast Feeding ◽  
Protein Energy Malnutrition ◽  
Control Group ◽  
Case Group ◽  
Feeding Practice ◽  
Prelacteal Feeding ◽  
College Hospital ◽  
Major Health Problem ◽  
Protein Energy ◽  
Breast Fed

Background: The predominant form of malnutrition is commonly called proteincalorie malnutrition. Protein Energy Malnutrition (PEM) is still a major health problem in children of developing countries including Bangladesh. The causes of malnutrition are multifactorial including nutritional factors, socioeconomic factors, health status of the mothers and repeated infections in children.Objective: To explore the information regarding the breast feeding practices of children suffering from Protein-Energy Malnutrition.Methods: This case control study was conducted in Chittagong Medical College Hospital from November 2006 to April 2007. A total of 65 controls and 65 cases were selected consecutively for the purpose of the study. Their mothers were interviewed with help of structured questionnaire containing all the variables of interest to attain the study objectives. The test statistics used to analyze the data were descriptive statistics and Chi-square (c2) or Fisher’s Exact Probability Test.Results: A significantly higher frequency of cases (67.7%) were given pre-lacteal feed, predominantly honey and sugar-water compared to control group (41.5%) (p = 0.008). Nearly 100% of controls were given colostrums compared to 75% of the cases. About one-third (31.3%) of the cases was exclusively breast-fed in comparison to 58.5% of the control group (p = 0.003). Over onequarter (27.7%) of the control were breast-fed upto 6 months of age, as opposed to only 1.5% cases (p < 0.001). Duration of predominant breast feeding for more than 6 months of age was also significantly higher in control group than that in case group (p = 0.001). Breast milk substitutes demonstrate their significant presence in cases (38.5%) than that in controls (9%) (p = 0.003).Conclusion: The study showed that rejection of colostrums, practice of prelacteal feeding, delayed initiation of breast feeding, early cessation of exclusive breast feeding and use of formula milk all were significantly higher in the malnourished group of children than those in their normal counterpart.Chatt Maa Shi Hosp Med Coll J; Vol.14 (2); Jul 2015; Page 43-47

scholarly journals Efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia: a protocol for randomised double-blind controlled clinical trial

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e041958
Author(s):  
Nirmani Yasara ◽  
Nethmi Wickramarathne ◽  
Chamila Mettananda ◽  
Aresha Manamperi ◽  
Anuja Premawardhena ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sri Lanka ◽  
Intervention Group ◽  
Primary Outcome Measure ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Scientific Publications ◽  
Double Blind ◽  
Fetal Haemoglobin

IntroductionDespite being one of the first diseases to be genetically characterised, β-thalassaemia remains a disorder without a cure in a majority of patients. Most patients with β-thalassaemia receive only supportive treatment and therefore have a poor quality of life and shorter life spans. Hydroxyurea, which has shown to induce fetal haemoglobin synthesis in human erythroid cells, is currently recommended for the treatment of sickle cell disease. However, its clinical usefulness in transfusion-dependent β-thalassaemia is unclear. Here, we present a protocol for a randomised double-blind controlled clinical trial to evaluate the efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia.Methods and analysisThis single-centre randomised double-blind placebo-controlled clinical trial is conducted at the Thalassaemia Centre of Colombo North Teaching Hospital, Ragama, Sri Lanka. Adult and adolescent patients with haematologically and genetically confirmed transfusion-dependent β-thalassaemia are enrolled and randomised into the intervention or control group. The intervention group receives oral hydroxyurea 10–20 mg/kg daily for 6 months, while the control group receives a placebo which is identical in size, shape and colour to hydroxyurea without its active ingredient. Transfused blood volume, pretransfusion haemoglobin level, fetal haemoglobin percentage and adverse effects of treatment are monitored during treatment and 6 months post-treatment. Cessation or reduction of blood transfusions during the treatment period will be the primary outcome measure. The statistical analysis will be based on intention to treat.Ethics and disseminationEthical approval has been obtained from the Ethics Committee of Faculty of Medicine, University of Kelaniya (P/116/05/2018) and the trial is approved by the National Medicinal Regulatory Authority of Sri Lanka. Results of the trial will be disseminated in scientific publications in reputed journals.Trial registration numberSLCTR/2018/024; Pre-results.

scholarly journals A randomized controlled clinical trial of the effect of supportive counseling on mental health in Iranian mothers of premature infants

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Leila Seiiedi-Biarag ◽  
Mojgan Mirghafourvand ◽  
Khalil Esmaeilpour ◽  
Shirin Hasanpour
Keyword(s):  
Mental Health ◽  
Clinical Trial ◽  
Premature Infants ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Postpartum Bonding ◽  
Supportive Counseling

Abstract Background Premature birth can affect maternal mental health. Considering that the mental health disorder in mothers may play a vital role in the growth and development of their children, therefore, this study was conducted to determine the effect of supportive counseling on mental health (primary outcome), mother-child bonding and infant anthropometric indices (secondary outcomes) in mothers of premature infants. Methods This randomized controlled clinical trial was carried out on 66 mothers with hospitalized neonates in the NICU of Alzahra hospital in Tabriz- Iran. Participants were randomly allocated into two groups of intervention (n = 34) and control (n = 32) through a block randomization method. The intervention group received 6 sessions of supportive counseling (45–60 minutes each session) by the researcher, and the control group received routine care. Questionnaires of Goldberg General Health and the postpartum bonding were completed before the intervention (first 72 hours postpartum) and 8 weeks postpartum. Also, the anthropometric index of newborns were measured at the same time. Results There was no statistically significant difference between the two groups in terms of socio-demographic characteristics. After the intervention, based on ANCOVA with adjusting the baseline score, mean score of mental health (AMD: -9.8; 95% Confident Interval (95% CI): -12.5 to -7.1; P < 0.001) and postpartum bonding (AMD: -10.0; 95% CI: -0.6 to 13.9; P < 0.001) in the counseling group was significantly lower than those of the control group; however, in terms of weight (P = 0.536), height (P = 0.429) and head circumference (P = 0.129), there was no significant difference between the two groups. Conclusions Supportive counseling may improve mental health and postpartum bonding in mothers of premature infants. Thus, it may be recommendable for health care providers to offer it to mothers. Trial registration Iranian Registry of Clinical Trials (IRCT): IRCT20120718010324N45. Date of registration: October 29, 2018.

Outcome of lymph node tuberculosis management with conventional treatment with and without prednisolone

2021 ◽  
pp. 004947552098474
Author(s):  
Arjuman Sharmin ◽  
Ali Hossain ◽  
Nazmul Islam ◽  
Zakir H Sarker ◽  
Sheikh S Hossain ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Lymph Node ◽  
Complete Resolution ◽  
Conventional Treatment ◽  
Symptomatic Improvement ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Open Label ◽  
Lymph Node Tuberculosis ◽  
And Control

The outcome of lymph node tuberculosis (LNTB) management with conventional anti-tubercular treatment alone is unsatisfactory. We conducted a randomised open-label controlled clinical trial in the Department of Respiratory Medicine in Government Institute of Dhaka, Bangladesh from April 2017 to March 2019. Compared with controls, 54 patients of LNTB received category 1 anti-tubercular treatment with additional prednisolone after randomisation. Complete resolution in 21/54 (75%) and 7 (26.9%), symptomatic improvement in 26 (92.9%) and 22 (84.6%) and complications in 11 (39.28%) and 16 (61.53%) were observed in the treatment and control group, respectively. Thus, we recommend the use of steroids in this setting.

scholarly journals Supragingival plaque removal with and without dentifrice: a randomized controlled clinical trial

2012 ◽  
Vol 23 (3) ◽  
pp. 235-240 ◽  
Author(s):  
Fabricio B. Zanatta ◽  
Raquel P. Antoniazzi ◽  
Tatiana M. P. Pinto ◽  
Cassiano K. Rösing
Keyword(s):  
Clinical Trial ◽  
Test Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Separate Analysis ◽  
Randomized Controlled Clinical Trial ◽  
Significance Level ◽  
Plaque Removal ◽  
Randomized Controlled ◽  
Removal Capacity

The aim of this study was to compare the efficacy of dental plaque removal by brushing with and without conventional dentifrice. Twenty-four students aged 17 to 28 years participated in this randomized controlled clinical trial. Quadrants 1-3 or 2-4 were randomly allocated to the test group (brushing without dentifrice) or control group (brushing with dentifrice). After 72 h of cessation of oral hygiene, Quigley & Hein (Turesky) plaque index was assessed before and after brushing by a calibrated and blind examiner. Overtime and intergroup comparisons were performed by Student's paired sample t-test at 5% significance level. The results showed that both groups after toothbrushing presented statistically significant reductions in plaque, with no differences between them (from 3.06 ± 0.54 to 1.27 ± 0.26 versus from 3.07 ± 0.52 to 1.31 ± 0.23). A separate analysis of the buccal and lingual aspects also showed no significant differences between groups. It may be concluded that the use of a conventional dentifrice during toothbrushing does not seem to enhance plaque removal capacity.

scholarly journals Curcumin nanomicelle versus curcumin improves lipid profile, stress oxidative factors and inflammatory markers in patients undergoing coronary elective angioplasty; A Randomized Clinical Trial

2019 ◽  
Author(s):  
Bijan Helli ◽  
Hadis Gerami ◽  
Maria Kavianpour ◽  
Habib Heybar ◽  
Seyed Kianoosh Hosseini ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Lipid Profile ◽  
Inflammatory Markers ◽  
Interleukin 1 ◽  
Stress Index ◽  
Inflammatory Factors ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Stress Oxidative

Abstract Background: Curcumin exhibited antioxidant and anti-inflammatory effects. The aim of this study, assess and compare curcumin and nano- curcumin effects on lipid profile, oxidative stress index and inflammatory factors of heart patients.Methods: This Randomized, Double-Blind, Placebo-Controlled Clinical Trial conducted on 90 patients undergoing coronary elective angioplasty. Patients were randomly divided into 3 groups. The first group received a 500 mg capsule of curcumin daily. The second group received an 80 mg capsule of nano- curcumin daily. The placebo group also received capsules similar to curcumin for 8 weeks. Lipid profile, stress oxidative factors and inflammatory markers measured in baseline and end of the investigation.Results: At the end of study, statistically significant changes was seen in the total cholesterol (TC), triglyceride (TG) and low density lipoprotein (LDL) in the intervention groups to the control group (p<0.05). These changes in the nano-curcumin group were greater than the curcumin group. Curcumin and nano-curcumin supplementation also caused a statistically significant improvement in plasma levels of total antioxidant capacity (TAC), malondialdehyde (MDA), Superoxide dismutase (SOD), glutathione peroxidase (GSH-Px), high-sensitivity C-reactive protein (hs-CRP), Interleukin 1 beta (IL-1β) and tumor necrosis factor alpha (TNF-α) in comparison to the placebo (p<0.05).Conclusion: Complementary therapy of cardiovascular patients with curcumin and nano-curcumin supplements, could improve lipid profile, stress oxidative index and, inflammatory factors. The effects of curcumin on nano formula may be better for cardiac patients due to high bioavailability. However, further investigation is suggested in this regard.

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