Clinical trial NCT04025827: Weight Patterns in the Month After Birth
Official title: Weight Patterns in the Month After Birth: Relationship With Dietary Intake
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stunting
Wasting
Undernutrition
Feeding Patterns
Feeding; Difficult, Newborn
Feeding, Breast
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Makerere University
name: Aga Khan University
name: International Partnership for Human Development
name: Kathmandu University School of Medical Sciences
First posted: 2019-07-19
Enrollment: 741
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight for age z-score
timeFrame: 30 days
measure: Weight change relative to birth weight
timeFrame: 12 days
Secondary outcomes:
measure: Weight equal to or exceeding birth weight
timeFrame: 12 days of age
measure: Weight nadir
timeFrame: 30 days
measure: Age at weight nadir
timeFrame: 30 days
measure: Weight for length z-score
timeFrame: 30 days
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Bissau
country: Guinea-Bissau
facility: International Partnership for Human Development
city: Dhulikhel
country: Nepal
facility: Dhulikhel Hospital
city: Karachi
country: Pakistan
facility: Aga Khan University
city: Kampala
country: Uganda
facility: Makerere University
Study officials:
affiliation: University of California, San Francisco
name: Valerie Flaherman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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. No abstract available.
citation: 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(Suppl 1):3-11. doi: 10.1111/mcn.12283.
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, Ekstrom EC, Van de Perre P, Kankasa C, Sommerfelt H, Tylleskar 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.
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. doi: 10.1111/j.1651-2227.2007.00532.x. Epub 2007 Dec 3.
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):e20162625. doi: 10.1542/peds.2016-2625. Epub 2016 Nov 9.
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.
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.