Weight Patterns in the Month After Birth

Weight Patterns in the Month After Birth: Relationship With Dietary Intake

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.

Study Overview

Detailed 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 Type

Observational

Enrollment (Actual)

741

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bissau, Guinea-Bissau
        • International Partnership for Human Development
      • Dhulikhel, Nepal
        • Dhulikhel Hospital
      • Karachi, Pakistan
        • Aga Khan University
      • Kampala, Uganda
        • Makerere University
    • California
      • San Francisco, California, United States, 94122
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 day (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study will enroll singleton, healthy newborns with birth weight ≥2000 g and their mothers. Fathers and next oldest siblings also will be enrolled if available and if any indicated assent/consent is able to be obtained.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight for age z-score
Time Frame: 30 days
Weight for age z-score
30 days
Weight change relative to birth weight
Time Frame: 12 days
The difference between birth weight and current weight, expressed as a proportion of birth weight
12 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight equal to or exceeding birth weight
Time Frame: 12 days of age
Infant weight equal to or exceeding birth weight
12 days of age
Weight nadir
Time Frame: 30 days
Lowest weight in the first 30 days after birth, expressed as a proportion of birth weight
30 days
Age at weight nadir
Time Frame: 30 days
Age in days at the time of the lowest weight in the first 30 days after birth
30 days
Weight for length z-score
Time Frame: 30 days
Weight for length z-score
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2019

Primary Completion (Actual)

February 21, 2021

Study Completion (Actual)

February 21, 2021

Study Registration Dates

First Submitted

July 17, 2019

First Submitted That Met QC Criteria

July 17, 2019

First Posted (Actual)

July 19, 2019

Study Record Updates

Last Update Posted (Actual)

May 13, 2021

Last Update Submitted That Met QC Criteria

May 10, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A132356

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Six months after completion of this multi-component project, unless otherwise agreed with the funder, we will make fully de-identified data from this study publicly available in a manner and under conditions agreed to by the funder, as required by the funder's Open Access Policy.

IPD Sharing Time Frame

Six months after completion of the multi-component project which includes qualitative and quantitative assessment

IPD Sharing Access Criteria

Specified by the funder's Open Access Policy

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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