NCT04025827

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
741

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Geographic Reach
5 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 22, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2021

Completed
Last Updated

May 13, 2021

Status Verified

May 1, 2021

Enrollment Period

1.8 years

First QC Date

July 17, 2019

Last Update Submit

May 10, 2021

Conditions

StuntingWastingUndernutritionFeeding PatternsFeeding; Difficult, NewbornFeeding, Breast

Outcome Measures

Primary Outcomes (2)

  • Weight for age z-score

    Weight for age z-score

    30 days

  • Weight change relative to birth weight

    The difference between birth weight and current weight, expressed as a proportion of birth weight

    12 days

Secondary Outcomes (4)

  • Weight equal to or exceeding birth weight

    12 days of age

  • Weight nadir

    30 days

  • Age at weight nadir

    30 days

  • Weight for length z-score

    30 days

Interventions

Dietary intakeOTHER

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

Eligibility Criteria

AgeUp to 24 Hours
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • Birth weight ≥ 2000g.
  • Mother ≥18 years of age and intends to breastfeed for at least 6 months.
  • Mother anticipates availability for all study visits.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of California, San Francisco

San Francisco, California, 94122, United States

Location

International Partnership for Human Development

Bissau, Guinea-Bissau

Location

Dhulikhel Hospital

Dhulikhel, Nepal

Location

Aga Khan University

Karachi, Pakistan

Location

Makerere University

Kampala, Uganda

Location

Related Publications (7)

  • 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.

    PMID: 18207566BACKGROUND

  • 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.

    PMID: 27187906BACKGROUND

  • 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.

    PMID: 24950759BACKGROUND

  • 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.

    PMID: 18053000BACKGROUND

  • 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.

    PMID: 27940721BACKGROUND

  • 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.

    PMID: 25554815BACKGROUND

  • 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.

    PMID: 28107100BACKGROUND

MeSH Terms

Conditions

Growth DisordersCachexiaMalnutritionFeeding BehaviorBreast Feeding

Interventions

Eating

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsWeight LossBody Weight ChangesBody WeightSigns and SymptomsThinnessNutrition DisordersNutritional and Metabolic DiseasesBehavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaDigestive System Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Valerie Flaherman, MD, MPH

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2019

First Posted

July 19, 2019

Study Start

April 22, 2019

Primary Completion

February 21, 2021

Study Completion

February 21, 2021

Last Updated

May 13, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Six months after completion of the multi-component project which includes qualitative and quantitative assessment
Access Criteria
Specified by the funder's Open Access Policy

Locations

PA(1)NE(1)US(1)GU(1)UG(1)