Stunting Clinical Trial
Official title:
Weight Patterns in the Month After Birth: Relationship With Dietary Intake
NCT number | NCT04025827 |
Other study ID # | A132356 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 22, 2019 |
Est. completion date | February 21, 2021 |
Verified date | May 2021 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This is a prospective cohort study that will be conducted in four low income countries to describe newborn weight patterns in the first month after birth and their association with clinical and demographic factors including dietary intake.
Status | Completed |
Enrollment | 741 |
Est. completion date | February 21, 2021 |
Est. primary completion date | February 21, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 24 Hours |
Eligibility | Inclusion Criteria: - Birth weight = 2000g. - Mother =18 years of age and intends to breastfeed for at least 6 months. - Mother anticipates availability for all study visits. Exclusion Criteria: - Birth weight <2000g - Respiratory distress including tachypnea, head nodding, nasal flaring, chest retractions or grunting - Known major congenital anomalies including orofacial clefts, neural tube defects and congenital heart defects - Contraindication to breastfeeding at each site as determined by a site's national or sub-national health authorities - Twins and other multiples. - Newborns whose birth weight was not obtained in the first six hours. - Newborns whose mothers intend to move or otherwise become unavailable during the follow up period of 30 days after birth |
Country | Name | City | State |
---|---|---|---|
Guinea-Bissau | International Partnership for Human Development | Bissau | |
Nepal | Dhulikhel Hospital | Dhulikhel | |
Pakistan | Aga Khan University | Karachi | |
Uganda | Makerere University | Kampala | |
United States | University of California, San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | Aga Khan University, International Partnership for Human Development, Kathmandu University School of Medical Sciences, Makerere University |
United States, Guinea-Bissau, Nepal, Pakistan, Uganda,
Aguayo VM, Menon P. Stop stunting: improving child feeding, women's nutrition and household sanitation in South Asia. Matern Child Nutr. 2016 May;12 Suppl 1:3-11. doi: 10.1111/mcn.12283. — View Citation
Black RE, Allen LH, Bhutta ZA, Caulfield LE, de Onis M, Ezzati M, Mathers C, Rivera J; Maternal and Child Undernutrition Study Group. Maternal and child undernutrition: global and regional exposures and health consequences. Lancet. 2008 Jan 19;371(9608):243-60. doi: 10.1016/S0140-6736(07)61690-0. Review. — View Citation
Engebretsen IM, Jackson D, Fadnes LT, Nankabirwa V, Diallo AH, Doherty T, Lombard C, Swanvelder S, Nankunda J, Ramokolo V, Sanders D, Wamani H, Meda N, Tumwine JK, Ekström EC, Van de Perre P, Kankasa C, Sommerfelt H, Tylleskär T; PROMISE EBF-study group. Growth effects of exclusive breastfeeding promotion by peer counsellors in sub-Saharan Africa: the cluster-randomised PROMISE EBF trial. BMC Public Health. 2014 Jun 21;14:633. doi: 10.1186/1471-2458-14-633. — View Citation
Flaherman VJ, Schaefer EW, Kuzniewicz MK, Li S, Walsh E, Paul IM. Newborn Weight Loss During Birth Hospitalization and Breastfeeding Outcomes Through Age 1 Month. J Hum Lact. 2017 Feb;33(1):225-230. doi: 10.1177/0890334416680181. Epub 2017 Jan 20. — View Citation
Flaherman VJ, Schaefer EW, Kuzniewicz MW, Li SX, Walsh EM, Paul IM. Early weight loss nomograms for exclusively breastfed newborns. Pediatrics. 2015 Jan;135(1):e16-23. doi: 10.1542/peds.2014-1532. Epub 2014 Dec 1. — View Citation
Jakobsen MS, Sodemann M, Biai S, Nielsen J, Aaby P. Promotion of exclusive breastfeeding is not likely to be cost effective in West Africa. A randomized intervention study from Guinea-Bissau. Acta Paediatr. 2008 Jan;97(1):68-75. Epub 2007 Dec 3. — View Citation
Paul IM, Schaefer EW, Miller JR, Kuzniewicz MW, Li SX, Walsh EM, Flaherman VJ. Weight Change Nomograms for the First Month After Birth. Pediatrics. 2016 Dec;138(6). pii: e20162625. Epub 2016 Nov 9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Weight for age z-score | Weight for age z-score | 30 days | |
Primary | Weight change relative to birth weight | The difference between birth weight and current weight, expressed as a proportion of birth weight | 12 days | |
Secondary | Weight equal to or exceeding birth weight | Infant weight equal to or exceeding birth weight | 12 days of age | |
Secondary | Weight nadir | Lowest weight in the first 30 days after birth, expressed as a proportion of birth weight | 30 days | |
Secondary | Age at weight nadir | Age in days at the time of the lowest weight in the first 30 days after birth | 30 days | |
Secondary | Weight for length z-score | Weight for length z-score | 30 days |
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