Effect of Tahneek on Hypoglycemia in Newborn Infants

Premature Infant Clinical Trial

— THIN  

Official title:

Effect of Tahneek With Dates on Hypoglycemia in Newborn Infants: A Randomised Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03726697
• Other study ID #: KAIMRC
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: May 22, 2019

Study information

• Verified date: May 2019
• Source: King Abdullah International Medical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 324
• Est. completion date: May 22, 2019
• Est. primary completion date: May 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Hour

Eligibility

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

Related Conditions & MeSH terms

• Fetal Growth Retardation
• Fetal Macrosomia
• Hypoglycemia
• Infant, Small for Gestational Age
• Intrauterine Growth Restriction
• Macrosomia, Fetal
• Neonatal Hypoglycemia
• Neonatal; Hypoglycemia, Diabetes, Maternal
• Premature Infant

Intervention

Other:
• Tahneek
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

Locations

Country	Name	City	State
Saudi Arabia	King Abdulaziz Medical City	Jeddah	WR

Sponsors (1)

Lead Sponsor	Collaborator
King Abdullah International Medical Research Center

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	first 48 hours of life
Primary	Admission to NICU for hypoglycemia	infants at-risk will be followed to measure NICU admission data and glucose values during hospitalization.	first 48 hours of life
Secondary	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.	48 hours
Secondary	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.	6 months
Secondary	Pain scale	Pain scale as measured by Neonatal intensive pain scale during the first 48 hrs of hospital stay	48 hours