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Showing 1-9 of 9 trials
NCT07424846
The ground-breaking Prevention of Prematurity and Xylitol (PPaX) cluster randomized controlled clinical trial was conducted in Lilongwe, Malawi and enrolled approximately 10,069 pregnant individuals seeking to evaluate the impact of xylitol-containing chewing gum compared to no chewing gum on reducing the occurrence of maternal periodontal disease, preterm birth, and low birthweight offspring. The premise of this study centers upon the numerous publications supporting a strong association between maternal periodontal disease and preterm birth. Given that xylitol-containing chewing gum is considered a prebiotic and known to reduce cariogenic and periodontopathic bacteria, the study evaluated and discovered a statistically significant reduction in maternal periodontal disease, preterm birth, and low birthweight offspring among pregnant individuals who chewed xylitol-containing chewing gum. While PPaX demonstrated the efficacy of xylitol to reduce preterm birth (PTB), the study had important limitations: (a) PPaX was an unblinded cluster-randomized study with only 8 clusters, 4 with xylitol-containing chewing gum and 4 without any gum (not placebo-controlled); (b) PPaX used a suboptimal dose of 2 grams of xylitol daily which may have reduced the effectiveness of the intervention given that recent literature suggests 5-10 grams/day more effectively improve oral health; and (c) PPaX did not evaluate infant mortality nor early neurodevelopmental outcomes. Notably, reducing fetal exposure to periodontal disease (PD) as well as PTB may improve neurodevelopmental outcomes for offspring as both prematurity and fetal exposure to inflammation are well-documented risk factors for neurodevelopmental delay (NDD) and infant mortality. The investigators will conduct a double-blind, placebo-controlled, individually randomized clinical trial with 3 arms among Malawian pregnant individuals (n=6000) at \<20 weeks of pregnancy with the co-primary outcomes being the incidence of PTB and low birthweight offspring. The 3 study arms (n=2000 each) will be (a) an optimized dose of xylitol-containing chewing gum (6.4 grams/day), (b) the PPaX trial xylitol dose (2.1 grams/day), or (c) flavored sorbitol gum base (placebo control). This trial overcomes the PPaX trial's limitations and will definitively answer whether xylitol prevents PTB in Malawi. The investigators will additionally collect biospecimens from a random sampling of the participants for biobanking for later analysis of inflammatory and microbiome alterations that may occur with xylitol exposure compared with placebo. The investigators hypothesize that pregnant individuals who chew xylitol-containing chewing gum will have a significant reduction in periodontal disease metrics at 28-30 weeks' gestation (e.g. bleeding on probing) as well as offspring with improved neurodevelopmental outcomes as assessed by the Bayley Scales of Infant and Toddler Development 4th edition and reduced risk of adverse pregnancy outcomes including preterm birth.
NCT06937580
Kangaroo Care, which includes skin-to-skin contact, exclusive breastfeeding, and timely follow-up, is a proven method to reduce neonatal morbidity and mortality in low-resource settings where the risks of prematurity, neonatal hypothermia, and neonatal mortality are high. However, numerous challenges such as inadequate knowledge, financial constraints, cultural norms, stigma, and limited social support impede its effective practice among mothers of low birthweight infants. To address these barriers, the intervention consists of informational, emotional and motivational support from trained peers and a box with warmth-related items to support the adoption and sustainment of Kangaroo Care at home. The investigators will enroll 328 mothers of low birthweight infants, who intend to initiate Kangaroo Care at two tertiary hospitals in Ghana, in a prospective randomized controlled trial. The trial aims to evaluate the effectiveness of the intervention in increasing exclusive breastfeeding rates and the duration of skin-to-skin contact at 7 and 28 days post-hospital discharge. Mothers in the control group will receive the standard of care, which consists of one counseling session on Kangaroo Care before discharge and a follow-up phone call after discharge. In addition to the standard of care, mothers in the intervention group will receive five one-on-one peer support sessions over one month, along with a box containing a hat, socks, a specialized wrap to support skin-to-skin contact, soap for hand hygiene, and a temperature monitoring device that alerts mothers if their infant becomes hypothermic. Using surveys, outcome data will be collected from both study groups at enrollment in the hospital, and at 7 and 28 days after discharge at participants' homes. Additionally, in-depth interviews will be conducted with 10-15 mothers from the intervention group, 10-15 healthcare workers, and all six peer supporters delivering the intervention. These interviews will explore the implementation of the intervention and contextualize barriers and facilitators from the perspectives of different stakeholders.
NCT04002908
Globally, 15% of all babies, amounting to 20 million infants each year, are born low birthweight (LBW), defined less than 2500 grams (5.5 lbs). Compared to normal weight infants, LBW infants are at higher risk of morbidity, mortality, and poor growth (Risnes et al 2011; Larroque et al 2001; WHO 2006). The main causes of LBW are preterm birth, intrauterine growth restriction (IUGR), or their combination. Unfortunately, there is a paucity of information around feeding practices and optimal feeding strategies for this population, particularly for LBW infants who struggle with breastfeeding or growth. This study hopes to address these gaps.
NCT03641209
In the present trial, early, intravenous paracetamol is compared to placebo in extremely premature or low birth weight infants in order to evaluate the effect on ductal closure.
NCT06277869
Globally, over 15 million neonates are born preterm each year. They account for approximately 30% of global neonatal deaths and 19% of total neonatal deaths in Bangladesh. They usually die because they cannot maintain normal temperature due to their weight, immature skin and underdeveloped thermal regulatory capacity of the brain. Maintaining continuous Kangaroo Mother Care (KMC) for at least 16-20 hours/day, is sometimes not feasible for mothers or caregivers. In addition, we also have the challenge of keeping preterm or low birthweight (LBW) neonates warm during transportation. The scientists at icddr,b, Johns Hopkins University, and George Mason University developed the thermal jacket for keeping preterm or LBW neonate warm. We have already completed the laboratory trial on mannquins and clinical safety trial among preterm or LBW neonates. Now, we propose to build on our previous work by systematically testing the effectiveness trial of the 'thermal jacket' among preterm or LBW neonates at clinical settings. Hypothesis: Thermal jacket can increase the rate of euthermia among the preterm or LBW neonates in the selected health facilities in Bangladesh. Objectives: The aim of this study is to test whether the thermal jacket can attain and maintain euthermia of preterm or LBW neonates in clinical settings of Bangladesh.
NCT02605369
Universal coverage of good quality facility based care globally could prevent nearly 113,000 maternal deaths, 531,000 stillbirths and 1.3 million neonatal deaths annually by 2020. Yet, only 57% of pregnant Ugandan women choose to deliver at health facilities. This unacceptably low coverage of facility based births could explain, in part, the high maternal and perinatal mortality estimates in Uganda. While multiple studies have examined factors associated with this low utilization of health services around the time of birth, there is inadequate implementation research exploring the best systematic methods that could promote uptake and scale up of facility based births. This study will therefore examine the effect of an intervention package (peer counselling by pregnancy buddies on facility based births, mobile phone messaging promoting facility based births and provision of mama-kits) on the frequency of facility based births and perinatal mortality. The study, a cluster randomized community based intervention trial in post-conflict Northern Uganda, will provide data crucial in framing national policy regarding measures to promote the use of health facilities.
NCT05836961
The purpose of this study is to evaluate the impact of Benazir Nashonuma Program (BNP) which includes specialized nutritious food (SNF) augmented with specific reproductive health interventions during pregnancy on proportion of low birthweight babies and stunting among children, in low income setting of Pakistan. The study aims to answer if: 1. Utilization of Benazir Nashonuma Program (BNP) among pregnant women is effective in reducing the proportion of low birthweight babies, compared to pregnant women who are not utilizing the program, among low income setting population. 2. Utilization of Benazir Nashonuma Program (BNP) is effective in reducing the proportion of stunting among children, compared to those not utilizing the program, among low income setting population. Participants who are enrolled in the Benazir Nashonuma Program (receiving intervention) and those who are not enrolled (not receiving intervention) will be followed throughout pregnancy till delivery. After delivery mother-baby dyad will be followed for a period of 12 months. Compliance of supplementation will be measured, and outcomes (low birthweight and stunting) observed throughout the follow up.
NCT04171388
The ENAT study will test the impact of packages of antenatal interventions to enhance maternal nutrition and manage pregnancy infections on the outcomes of infant birth size, gestational length, and infant growth in the first 6 months of life. Approximately 5,280 pregnant women will be enrolled into the study from 12 health centers in the Amhara region of Ethiopia. Routine antenatal care will be strengthened in all health centers, and six health centers will be randomized to additionally provide a nutritional intervention including daily multiple-micronutrient or a fortified balanced-energy protein supplement for malnourished women. Women across all 12 health centers will be individually randomized to receive one of three infection management interventions in pregnancy: 1) enhanced infection management package (screening-treatment for urinary tract infections and sexually transmitted infections, presumptive deworming); 2) presumptive azithromycin (2g at \<24 wks and a second dose at least 4 weeks later); or 3) placebo. The women and their infants will be followed until 6 months postpartum. Outcomes of interest include birth size (weight, length), gestational age, maternal weight gain in pregnancy, maternal anemia, antimicrobial resistance, and infant size at 6 months.
NCT01959737
The first hours after birth are a sensitive period for promotion of optimal mother-child-interaction and secure attachment. Maternal sensitivity and responsivness are high in the first hours after birth due to high oxytocin levels. Developing optimal mother-child-interaction is more difficult for preterm mothers because mother and child are separated after birth and the preterm infant is not able to show strong signs to promote maternal sensitivity. We hypothesize that promoting skin-to-skin contact of VLBW infants and their mothers for 60 minutes within the first hours after birth improves mother-child-interaction at 5 to 6 months corrected age. We also hypothesize that reactivity of HPA axis and molecular patterns of stress signaling pathways differ in preterm infant with or without SSC after birth.