Weight Patterns in the Month After Birth

Stunting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04025827
• Other study ID #: A132356
• Status: Completed
• Start date: April 22, 2019
• Est. completion date: February 21, 2021

Study information

• Verified date: May 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Feeding Patterns
• Feeding, Breast
• Feeding; Difficult, Newborn
• Malnutrition
• Stunting
• Undernutrition
• Wasting

Intervention

Other:
• Dietary intake
We will collect detailed data on dietary intake and weight for healthy newborns in four low income countries.

Locations

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

Sponsors (5)

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

Countries where clinical trial is conducted

United States,  Guinea-Bissau,  Nepal,  Pakistan,  Uganda, 

References & Publications (7)

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

Outcome

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