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StuntingNCT04025827

Weight Patterns in the Month After Birth

An observational study of Stunting and Wasting, run by University of California, San Francisco at 5 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages Up to 24 hoursHealthy volunteers can take part
Conditions the study is for
Stunting, Wasting, Undernutrition
What is being tested?
Dietary intake
How many people
741 participants
Where
5 sitesin 5 countries
Study dates
22 Apr 2019to 21 Feb 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 24 hours
  • All sexes
  • Healthy volunteers accepted
  • Child

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.

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

5 sites in 5 countries.

5 sites in 5 countries

United States1 site

  • University of California, San Francisco

    San Francisco, California, 94122

Other trials in United States

Guinea-Bissau1 site

  • International Partnership for Human Development

    Bissau

Other trials in Guinea-Bissau

Nepal1 site

  • Dhulikhel Hospital

    Dhulikhel

Other trials in Nepal

Pakistan1 site

  • Aga Khan University

    Karachi

Other trials in Pakistan

Uganda1 site

  • Makerere University

    Kampala

Other trials in Uganda

About this study

Official title: 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.

Read the 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.

Being tested
Dietary intake
Medical subject headings
Growth Disorders, Cachexia, Malnutrition, Feeding Behavior, Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dietary intakeOther

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight for age z-score

    Weight for age z-score

    Measured: 30 days

  2. Weight change relative to birth weight

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

    Measured: 12 days

Secondary outcomes (4)

  1. Weight equal to or exceeding birth weight

    Infant weight equal to or exceeding birth weight

    Measured: 12 days of age

  2. Weight nadir

    Lowest weight in the first 30 days after birth, expressed as a proportion of birth weight

    Measured: 30 days

  3. Age at weight nadir

    Age in days at the time of the lowest weight in the first 30 days after birth

    Measured: 30 days

  4. Weight for length z-score

    Weight for length z-score

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2019
  2. Study start22 Apr 2019
  3. Primary completion21 Feb 2021
  4. Study completion21 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
741 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04025827
Sponsor's protocol ID
A132356
Status last verified
May 2021
First submitted
17 Jul 2019
Last updated
13 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 18207566

  • 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.

    PubMed 27187906

  • 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.

    PubMed 24950759

  • 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.

    PubMed 18053000

  • 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.

    PubMed 27940721

  • 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.

    PubMed 25554815

  • 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.

    PubMed 28107100

Questions about this trial

What is this clinical trial studying?

An observational study of Stunting and Wasting, run by University of California, San Francisco at 5 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States, Guinea-Bissau, Nepal, Pakistan, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight for age z-score (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04025827, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2021.

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