Weight Patterns in the Month After Birth

Sponsor

University of California, San Francisco (Other)

Overall Status

Completed

CT.gov ID

NCT04025827

Collaborator

Makerere University (Other), Aga Khan University (Other), International Partnership for Human Development (Other), Kathmandu University School of Medical Sciences (Other)

741

Enrollment

Locations

Actual Duration (Months)

148.2

Patients Per Site

6.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Stunting Wasting Undernutrition Feeding Patterns Feeding; Difficult, Newborn Feeding, Breast	Other: Dietary intake

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 Design

Study Type:

Observational

Actual Enrollment :

741 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 22, 2019

Actual Primary Completion Date :

Feb 21, 2021

Actual Study Completion Date :

Feb 21, 2021

Outcome Measures

Primary Outcome Measures

Weight for age z-score [30 days]
Weight for age z-score
Weight change relative to birth weight [12 days]
The difference between birth weight and current weight, expressed as a proportion of birth weight

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 24 Hours

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Francisco	San Francisco	California	United States	94122
2	International Partnership for Human Development	Bissau		Guinea-Bissau
3	Dhulikhel Hospital	Dhulikhel		Nepal
4	Aga Khan University	Karachi		Pakistan
5	Makerere University	Kampala		Uganda

Sponsors and Collaborators

University of California, San Francisco
Makerere University
Aga Khan University
International Partnership for Human Development
Kathmandu University School of Medical Sciences

Investigators

Principal Investigator: Valerie Flaherman, MD, MPH, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT04025827

Other Study ID Numbers:

A132356

First Posted:

Jul 19, 2019

Last Update Posted:

May 13, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Malnutrition

Study Results

No Results Posted as of May 13, 2021