CompletedNot Applicable

Weight Patterns in the Month After Birth

United States, Guinea-Bissau, Nepal741 participantsStarted 2019-04-22

Plain-language 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.

Who can participate

Age range

24 Hours

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Weight for age z-score

Timeframe: 30 days

Weight change relative to birth weight

Timeframe: 12 days

Trial details

NCT IDNCT04025827

SponsorUniversity of California, San Francisco

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-02-21

View on ClinicalTrials.gov More Stunting trials

Who can participate

Age range

24 Hours

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.