scholarly journals The Kansas University DHA Outcomes Study (KUDOS) clinical trial: long-term behavioral follow-up of the effects of prenatal DHA supplementation

2019 ◽  
Vol 109 (5) ◽  
pp. 1380-1392 ◽  
Author(s):  
John Colombo ◽  
D Jill Shaddy ◽  
Kathleen Gustafson ◽  
Byron J Gajewski ◽  
Jocelynn M Thodosoff ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Preterm Birth ◽  
Visual Attention ◽  
Maternal Blood ◽  
Chain Polyunsaturated Fatty Acid ◽  
Long Term Effects ◽  
Double Blind ◽  
Early Preterm Birth

ABSTRACT Background Docosahexaenoic acid (DHA) is a long-chain polyunsaturated fatty acid that has been linked to improved vision and cognition in postnatal feeding studies and has been consistently associated with reduction of early preterm birth in prenatal supplementation trials. This is a report of the first long-term follow-up of infants from mothers receiving prenatal DHA supplementation in a US cohort. Objective Our objective was to evaluate the efficacy of the prenatal supplementation on both global and granular longitudinal assessments of cognitive and behavioral development. Methods In a randomized double-blind clinical trial, mothers received either 600 mg/d of DHA or a placebo beginning at 14.5 weeks of gestation and capsules were provided until delivery. Children from those pregnancies were followed by cognitive and behavioral assessments administered from 10 mo through 6 y of age. From 301 mothers in the initial study, ∼200 infants completed the longitudinal schedule. Results Although this intervention had been shown to reduce high-risk pregnancies and improve visual attention in infants during the first year, only a few positive long-term effects of prenatal DHA supplementation emerged from analyses of this follow-up. Increases in maternal blood DHA during pregnancy were related to verbal and full scale intelligence quotient (IQ) scores at 5 and 6 y, but these effects disappeared after controlling for SES. Maternal blood DHA concentrations at delivery were unrelated to outcomes, although maternal DHA at enrollment was related to productive vocabulary at 18 mo. Conclusions Although prenatal DHA supplementation substantially reduced early preterm birth and improved visual attention in infancy in this sample, no consistent long-term benefits were observed into childhood. Increases in maternal blood DHA concentration in pregnancy were related to higher IQs but this effect was confounded with SES and disappeared when SES was statistically controlled. This trial was registered at http://www.clinicaltrials.gov as NCT00266825 and NCT02487771.

scholarly journals Long-term effects of a modified, low-protein infant formula on growth and body composition: Follow-up of a randomized, double-blind, equivalence trial

2021 ◽  
Author(s):  
Stefanie M.P. Kouwenhoven ◽  
Nadja Antl ◽  
Martijn J.J. Finken ◽  
Jos W.R. Twisk ◽  
Eline M. van der Beek ◽  
...  
Keyword(s):  
Body Composition ◽  
Infant Formula ◽  
Long Term Effects ◽  
Double Blind ◽  
Equivalence Trial ◽  
Low Protein

The long-term effects of homeopathic treatment of chronic headaches: one year follow-up and single case time series analysis

2001 ◽  
Vol 90 (02) ◽  
pp. 63-72 ◽  
Author(s):  
H Walach ◽  
T Lowes ◽  
D Mussbach ◽  
U Schamell ◽  
W Springer ◽  
...  
Keyword(s):  
Time Series ◽  
Single Case ◽  
Double Blind Study ◽  
Long Term Effects ◽  
Double Blind ◽  
Homeopathic Treatment ◽  
Chronic Headaches ◽  
One Year

AbstractLittle is known about long-term effects of homeopathic treatment. Following a double-blind, placebo controlled trial of classical homeopathy in chronic headaches, we conducted a 1-year observational study of 18 patients following the double-blind phase, and a complete follow-up study of all trial participants. Eighteen patients received free treatment for daily diary data (frequency, intensity, duration of headaches) over the course of 1 y. All patients enrolled in the double-blind study were sent a 6-week headache diary, a follow-up questionnaire, a personality inventory and a complaint list. Eighty-seven, of the original 98 patients enrolled returned questionnaires, 81 returned diaries. There was no additional change from the end of the trial to the one-year follow-up. The improvement seen at the end of the 12-week trial was stable after 1 y. No differential effects according to treatment after the trial could be seen. Patients with no treatment following the trial had the most improvement after 1 y. Five of 18 patients can be counted responders according to ARIMA analysis of single-case time-series. Patients with double diagnoses and longer treatment duration tended to have clearer improvements than the rest of the patients. Approximately 30% of patients in homeopathic treatment will benefit after 1 y of treatment. There is no indication of a specific, or of a delayed effect of homeopathy.

scholarly journals 531: Long-term effects of cervical pessary for preterm birth prevention in twin pregnancy with short cervix: a 3 years follow-up of the ProTwin trial

2016 ◽  
Vol 214 (1) ◽  
pp. S287 ◽  
Author(s):  
Janneke van 't Hooft ◽  
Cuny Cuijpers ◽  
Johanna H. van der Lee ◽  
Sophie Liem ◽  
Ewoud Schuit ◽  
...  
Keyword(s):  
Preterm Birth ◽  
Twin Pregnancy ◽  
Long Term Effects ◽  
Short Cervix ◽  
Cervical Pessary

scholarly journals Long-term follow-up of children exposed in-utero to progesterone treatment for prevention of preterm birth: study protocol of the AMPHIA follow-up

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e053066
Author(s):  
Noor E Simons ◽  
Emilie V J van Limburg Stirum ◽  
Aleid G van Wassenaer-Leemhuis ◽  
Martijn J J Finken ◽  
Cornelieke S H Aarnoudse-Moens ◽  
...  
Keyword(s):  
Preterm Birth ◽  
Randomised Trial ◽  
Multiple Gestation ◽  
Long Term Effects ◽  
Follow Up Study ◽  
Multiple Gestations ◽  
Progesterone Treatment ◽  
Long Term Follow Up

IntroductionPreterm birth is one of the main problems in obstetrics, and the most important cause of neonatal mortality, morbidity and neurodevelopmental impairment. Multiple gestation is an important risk factor for preterm birth, with up to 50% delivering before 37 weeks. Progesterone has a role in maintaining pregnancy and is frequently prescribed to prevent (recurrent) preterm birth and improve pregnancy outcomes in high-risk patients. However, little is known about its long-term effects in multiple gestations. The objective of this follow-up study is to assess long-term benefits and harms of prenatal exposure to progesterone treatment in multiple gestations on child development.Methods and analysisThis is a follow-up study of a multicentre, double-blind, placebo-controlled randomised trial (AMPHIA trial, ISRCTN40512715). Between 2006 and 2009 women with a multiple gestation were randomised at 16–20 weeks of gestation to weekly injections 250 mg 17α-hydroxyprogesterone caproate or placebo, until 36 weeks of gestation or delivery. The current long-term follow-up will assess all children (n=1355) born to mothers who participated in the AMPHIA trial, at 11–14 years of age, with internationally validated questionnaires, completed by themselves, their parents and their teachers.Main outcomes are child cognition and behaviourAdditional outcomes are death (perinatal and up to age 14), gender identity, educational performance and health-related problems. We will use intention-to-treat analyses comparing experimental and placebo group. To adjust for the correlation between twins, general linear mixed-effects models will be used.Ethics and disseminationAmsterdam UMC MEC provided a waiver for the Medical Research Involving Human Subjects Act (W20_234#20.268). Results will be disseminated through peer-reviewed journals and summaries shared with stakeholders, patients and participants. This protocol is published before analysis of the results.Trial registration numberNL8933.

Poster 128: Long-term Effects of Physiotherapy-based Rehabilitation After Disk Herniation Operation: 12 Years' Follow-up of a Randomized Clinical Trial

PM&R ◽  
2010 ◽  
Vol 2 ◽  
pp. S61-S61
Author(s):  
Gerold Ebenbichler ◽  
Gabriele Amtmann ◽  
Silke Inschlag ◽  
Klaus Novak ◽  
Verena Pflüger ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Disk Herniation ◽  
Long Term Effects

scholarly journals Higher-Dose DHA Supplementation Modulates Immune Responses in Pregnancy and Is Associated with Decreased Preterm Birth

Nutrients ◽  
2021 ◽  
Vol 13 (12) ◽  
pp. 4248
Author(s):  
Christina J. Valentine ◽  
Aiman Q. Khan ◽  
Alexandra R. Brown ◽  
Scott A. Sands ◽  
Emily A. Defranco ◽  
...  
Keyword(s):  
Preterm Birth ◽  
Adaptive Design ◽  
Plasma Concentrations ◽  
Mechanistic Explanation ◽  
Maternal Blood ◽  
Double Blind ◽  
Maternal Immune System ◽  
Superiority Trial ◽  
Secondary Study ◽  
Early Preterm Birth

Pregnancy and parturition involve extensive changes in the maternal immune system. In our randomized, multi-site, double-blind superiority trial using a Bayesian adaptive design, we demonstrated that 1000 mg/day of docosahexaenoic acid (DHA) was superior to 200 mg/day in preventing both early preterm birth (less than 34 weeks’ gestation) and preterm birth (less than 37 weeks’ gestation). The goal of this secondary study is to compare the effects of 1000 mg/day versus 200 mg/day on maternal inflammation, a possible mechanism by which DHA may prevent preterm birth. Maternal blood samples were collected at enrollment (12–20 weeks’ gestation) and at delivery. Red blood cell DHA levels were measured by gas chromatography, and plasma concentrations of sRAGE, IL-6, IL-1β, TNFα, and INFγ were measured by ELISA. Data were analyzed for associations with the DHA dose, gestational age at birth, and preterm birth (<37 weeks). Higher baseline and lower delivery levels of maternal sRAGE were associated with a greater probability of longer gestation and delivery at term gestation. Higher-dose DHA supplementation increased the probability of a smaller decrease in delivery sRAGE levels. Higher IL-6 concentrations at delivery were associated with the probability of delivering after 37 weeks, and higher-dose DHA supplementation increased the probability of greater increases in IL-6 concentrations between enrollment and delivery. These data provide a proposed mechanistic explanation of how a higher dose of DHA during pregnancy provides immunomodulatory regulation in the initiation of parturition by influencing sRAGE and IL-6 levels, which may explain its ability to reduce the risk of preterm birth.

scholarly journals LONG-TERM OUTCOMES OF THE BENEFIT-FINDING GROUP INTERVENTION FOR ALZHEIMER’S FAMILY CAREGIVERS: A DOUBLE-BLIND RCT

2019 ◽  
Vol 3 (Supplement_1) ◽  
pp. S678-S678
Author(s):  
Sheung-Tak Cheng
Keyword(s):  
Depressive Symptoms ◽  
Group Intervention ◽  
Well Being ◽  
Benefit Finding ◽  
Role Overload ◽  
Long Term Effects ◽  
Post Intervention ◽  
Double Blind

Abstract This study examines the long-term effects of benefit-finding on caregivers’ depressive symptoms (primary outcome), and global burden, role overload, and psychological well-being (secondary outcomes). 96 Hong Kong Chinese caregivers of relatives with Alzheimer’s disease were randomly assigned to receive the benefit-finding intervention (BFT) or one of two control conditions, namely, simplified psychoeducation (lectures only; SIM-PE) or standard psychoeducation (STD-PE). Caregivers received four biweekly one-to-one interventions of three hours each at their own homes. Participants and raters were blind to experimental assignment. We focused on outcomes measured at 4- and 10-month follow-ups. The trajectories of intervention effects were modeled by BFT x time and BFT x time2 interaction terms. Mixed-effects regression showed significant BFT x time2 interaction effects on depressive symptoms against both control conditions, suggesting diminishing BFT effects over time. Z tests showed that, compared with controls, BFT participants reported substantial reductions in depressive symptoms at 4-month follow-up (d = -0.85 and -0.75 vs. SIM-PE and STD-PE respectively). At 10-month follow-up, BFT was indistinguishable from STD-PE whereas a moderate effect was observed in the comparison with SIM-PE (d = -0.52). In addition, some inconsistent effects on role overload were observed but no effect was found for the other outcome variables. It is concluded that benefit-finding is an efficacious intervention for depressive symptoms in Alzheimer caregivers, with strong effects in the medium-term post-intervention and possible moderate effects in the long-term.

The Long-Term Effects of Homeopathic Treatment of Chronic Headaches: 1 Year Follow Up

Cephalalgia ◽  
2000 ◽  
Vol 20 (9) ◽  
pp. 835-837 ◽  
Author(s):  
H Walach ◽  
T Lowes ◽  
D Mussbach ◽  
U Schamell ◽  
W Springer ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Double Blind Study ◽  
Long Term Effects ◽  
Delayed Effect ◽  
Double Blind ◽  
Homeopathic Treatment ◽  
Headache Diary ◽  
Chronic Headaches

Little is known about the long-term effects of homeopathic treatment. Following a double-blind, placebo-controlled trial of classical homeopathy in chronic headaches, we conducted a complete follow-up study of all trial participants. All patients enrolled in the double-blind study were sent a 6-week headache diary, a follow-up questionnaire. Eighty-seven of the original 98 patients enrolled returned questionnaires, 81 returned diaries. There was no additional change from the end of the trial to the 1-year follow up. The improvement seen at the end of the 12-week trial was stable after 1 year. No differential effects according to treatment after the trial could be seen. Patients with no treatment following the trial had the most improvement after 1 year. Approximately 30% of patients in homeopathic treatment will benefit after 1 year of treatment. There is no indication of a specific, or of a delayed effect of homeopathy.

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