CompletedNot Applicable

Effect of Tahneek on Hypoglycemia in Newborn Infants

Saudi Arabia324 participantsStarted 2018-11-01

Plain-language summary

Tahneek is an Arabic word which means putting something sweet such as dates, in the infant's mouth after the birth. Neonatal hypoglycemia is common in the first few days after birth. Up to 15 % of normal newborn babies will have low blood glucose concentrations. It has been demonstrated that treatment of neonatal hypoglycemia with oral dextrose gel was more effective than feeding alone in reversing the hypoglycemia, and also reduced the rate of NICU admission. investigators study is using dates to asses its effect on hypoglycemia in infants at risk.

Who can participate

Age range

1 Hour

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: * Babies at risk of hypoglycemia less than 1 hour old admitted to the normal nursery. * Infants of diabetic mothers (any type of diabetes) * Late Preterms (34 - 37 weeks' gestation) * Low birth weight (\< 2.5 kg ) or Small for gestational age * Large for gestational age (\> 4 kg or \> 90th centile on Fenton's growth chart) Exclusion Criteria: * Major congenital abnormality including severe cleft lip and palate. * Babies requiring NICU admission immediately after birth * Babies less than 34 weeks of age. * Babies whose parents refused to consent

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

Hypoglycemia

Timeframe: first 48 hours of life

Admission to NICU for hypoglycemia

Timeframe: first 48 hours of life

Trial details

NCT IDNCT03726697

SponsorKing Abdullah International Medical Research Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-05-22

View on ClinicalTrials.gov More Neonatal Hypoglycemia trials