Weight Patterns in the Month After Birth

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

Background: Worldwide, more than 50 million children under 5 are wasted (weight-for-length/height Z-score (WLZ) <-2) and over 150 million children under 5 are stunted (length/height-for-age Z-score (LAZ) <-2); such wasting and stunting often begin during infancy. Optimal early nutrition can prevent wasting and stunting. In low income countries, there is therefore a need to understand early weight patterns and how they relate to dietary intakes. Objectives: The proposed study will assess the relationship between infant dietary intake and weight change in low income countries by characterizing neonatal weight loss/gain patterns, dietary intake, and growth. Methodology: We will use a prospective cohort study design to describe early infant weight patterns and their relationship to dietary intake. Up to 880 newborns and their mothers will be enrolled in four countries: Guinea-Bissau, Nepal, Pakistan and Uganda (up to 220 newborns/site). Enrolled infants will be followed from birth until one month of age and will be assessed by anthropometry, dietary survey and hemoglobin measurement. Mothers will also be assessed for anthropometry and hemoglobin. Infants' fathers and next-oldest siblings will also be enrolled for anthropometry if available and willing to participate. Descriptive statistics will be used to describe sample characteristics. We will use various regression modeling techniques to examine the links between individual, family, and community characteristics and early infant weight patterns. Logistic regression models will also be used to consider potential confounding. Study findings will allow us to describe weight patterns in the first 30 days after birth and their relationship to the dietary intake during that time. We hypothesize that infants who lose 6% or more of their birth weight prior to beginning weight gain will have lower WAZ at 30 days of age. We also hypothesize that at 12 days of age, weight change relative to birth weight will be lower for infants born <2500g then for infants born ≥2500g. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04025827
Study type	Observational
Source	University of California, San Francisco
Contact
Status	Completed
Phase
Start date	April 22, 2019
Completion date	February 21, 2021

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.