Neonatal HypoglycemiaTHINNCT03726697
Effect of Tahneek on Hypoglycemia in Newborn Infants
A study testing Tahneek in people with Neonatal Hypoglycemia and Infant, Small for Gestational Age, run by King Abdullah International Medical Research Center at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 1 hour
- Conditions the study is for
- Neonatal Hypoglycemia, Infant, Small for Gestational Age, Macrosomia, Fetal
- What is being tested?
- Tahneek
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Nov 2018to 22 May 2019
- Phase
- Interventional
- 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 1 hour
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Tahneek With Dates on Hypoglycemia in Newborn Infants: A Randomised Control Trial
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.
Read the detailed description
Tahneek is an Arabic word which means putting something sweet such as dates, in the infant's mouth after the birth. It is a noble practice in Islam, with which the newborn is greeted upon entering into life, usually before milk feeds. It is done by rubbing a softened date on the palate of the new-born just after the birth. The tahneek also exercises the muscles of the mouth and helps with the circulation of blood in the mouth - this may help the baby to be able to suck and take mother's milk. Neonatal hypoglycemia is common in the first few days after birth. Up to 15 % but the incidence in babies with risk factors is much greater upto 50 % in infants of diabetic mothers, large and small babies and 66 % in preterm babies. Neonatal hypoglycemia is associated with brain damage, death and developmental delay in later life. Treatment of neonatal hypoglycemia with oral dextrose gel was more effective than feeding alone in reversing hypoglycemia, and thus reducing the rate of NICU admission for hypoglycemia. investigators study is using dates to asses its effect on hypoglycemia in infant at risk.
- Conditions
- Neonatal Hypoglycemia, Infant, Small for Gestational Age, Macrosomia, Fetal, Intrauterine Growth Restriction, Premature Infant, Neonatal; Hypoglycemia, Diabetes, Maternal
- Being tested
- Tahneek
- Keywords
- Tahneek, Neonatal; Hypoglycemia, Diabetes, Maternal, Neonatal Hypoglycemia, late preterm infants, Prevention, IUGR
- Medical subject headings
- Fetal Macrosomia, Fetal Growth Retardation, Premature Birth, Hypoglycemia, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TahneekOther
A single dose of soft date containing glucose equivalent to 200mg/kg at 1 h after birth will be massaged into the buccal mucosa of the palate and cheek from right to left side, until the date paste is fully absorbed
| Study group | Role | What they receive |
|---|---|---|
| Tahneek | Experimental | Infants receiving a single dose of soft date, prepacked by the pharmacy containing glucose equivalent to 200mg/kg at 1 hour after birth in the nursery. Receives: Other: Tahneek |
| CONTROL | No intervention | Infants at risk for transient neonatal hypoglycemia following standard-of-care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoglycemia
infants who meet eligibility criteria and parents have consented will receive a single dose of soft date, prepacked by the pharmacy containing glucose equivalent to 200mg/kg within 1 h after birth. Assess glucose level after 1 feed compared to controls with similar risk factors who are not received Tahneek. hypoglycemia defined as any blood glucose concentration < 2.6 mmol/L.
Measured: first 48 hours of life
Admission to NICU for hypoglycemia
infants at-risk will be followed to measure NICU admission data and glucose values during hospitalization.
Measured: first 48 hours of life
Secondary outcomes (3)
Hyperglycemia
infants at-risk who received Tahneek will be followed until hospital discharge to measure NICU admission data and glucose values during hospitalization. hyperglycemia defined as any blood glucose concentration > 10 mmol/L.
Measured: 48 hours
Breastfeeding
will asses the breastfeeding rate in the study infants, compared to controls at discharge from hospital (full or exclusive) and at 6months of age.
Measured: 6 months
Pain scale
Pain scale as measured by Neonatal intensive pain scale during the first 48 hrs of hospital stay
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start1 Nov 2018
- Primary completion22 May 2019
- Study completion22 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal HypoglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdullah International Medical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jubara Alallah, King Abdullah International Medical Research Center
- Investigators
- Jubara Alallah, MD, Principal investigator, King Abdullah International Medical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03726697
- Sponsor's protocol ID
- KAIMRC
- Acronym
- THIN
- Status last verified
- May 2019
- First submitted
- 30 Oct 2018
- Last updated
- 23 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tahneek With Dates on Hypoglycemia in Newborn Infants: A Randomised Control Trial
- ClinicalTrials.gov ID
- NCT03726697
- Acronym / sponsor ID
- THIN / KAIMRC
- Conditions
- Neonatal Hypoglycemia, Infant, Small for Gestational Age, Macrosomia, Fetal, Intrauterine Growth Restriction, Premature Infant, Neonatal; Hypoglycemia, Diabetes, Maternal
- Keywords
- Tahneek, Neonatal; Hypoglycemia, Diabetes, Maternal, Neonatal Hypoglycemia, late preterm infants, Prevention, IUGR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- King Abdullah International Medical Research CenterUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 22 May 2019 (actual)
- Study completion
- 22 May 2019 (actual)
- First posted
- 31 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Tahneek is an Arabic word which means putting something sweet such as dates, in the infant's mouth after the birth. It is a noble practice in Islam, with which the newborn is greeted upon entering into life, usually before milk feeds. It is done by rubbing a softened date on the palate of the new-born just after the birth. The tahneek also exercises the muscles of the mouth and helps with the circulation of blood in the mouth - this may help the baby to be able to suck and take mother's milk. Neonatal hypoglycemia is common in the first few days after birth. Up to 15 % but the incidence in babies with risk factors is much greater upto 50 % in infants of diabetic mothers, large and small babies and 66 % in preterm babies. Neonatal hypoglycemia is associated with brain damage, death and developmental delay in later life. Treatment of neonatal hypoglycemia with oral dextrose gel was more effective than feeding alone in reversing hypoglycemia, and thus reducing the rate of NICU admission for hypoglycemia. investigators study is using dates to asses its effect on hypoglycemia in infant at risk.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tahneek | Experimental | Other: TahneekInfants receiving a single dose of soft date, prepacked by the pharmacy containing glucose equivalent to 200mg/kg at 1 hour after birth in the nursery. |
| CONTROL | No intervention | –Infants at risk for transient neonatal hypoglycemia following standard-of-care. |
Who may qualify
- Ages
- Up to 1 hour
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TahneekA single dose of soft date containing glucose equivalent to 200mg/kg at 1 h after birth will be massaged into the buccal mucosa of the palate and cheek from right to left side, until the date paste is fully absorbed | Other | Tahneek |
Primary outcome
Hypoglycemia
Time frame: first 48 hours of life
infants who meet eligibility criteria and parents have consented will receive a single dose of soft date, prepacked by the pharmacy containing glucose equivalent to 200mg/kg within 1 h after birth. Assess glucose level after 1 feed compared to controls with similar risk factors who are not received Tahneek. hypoglycemia defined as any blood glucose concentration < 2.6 mmol/L.
Admission to NICU for hypoglycemia
Time frame: first 48 hours of life
infants at-risk will be followed to measure NICU admission data and glucose values during hospitalization.
3 secondary outcomes
Hyperglycemia
Time frame: 48 hours
Breastfeeding
Time frame: 6 months
Pain scale
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jubara Alallah, MD principal investigator
King Abdullah International Medical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tahneek in people with Neonatal Hypoglycemia and Infant, Small for Gestational Age, run by King Abdullah International Medical Research Center at 1 site in Saudi Arabia.
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 5 inclusion and 4 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 23 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. 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?
Hypoglycemia (time frame: first 48 hours of life). 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?
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 23 May 2019.