Effect of Tahneek on Hypoglycemia in Newborn Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

324 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2019-05-22

Brief Summary

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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.

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Detailed Description

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Parents and Statistician are blinded

Study Groups

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Tahneek

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.

Group Type EXPERIMENTAL

Tahneek

Intervention Type OTHER

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

CONTROL

Infants at risk for transient neonatal hypoglycemia following standard-of-care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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

Maximum Eligible Age

1 Hour

Eligible Sex

ALL

Accepts Healthy Volunteers

No