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NCT Number: NCT03726697

Effect of Tahneek on Hypoglycemia in Newborn Infants

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tahneek

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Hyperglycemia

    Time frame: 48 hours

    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.

  2. Breastfeeding

    Time frame: 6 months

    will asses the breastfeeding rate in the study infants, compared to controls at discharge from hospital (full or exclusive) and at 6months of age.

  3. Pain scale

    Time frame: 48 hours

    Pain scale as measured by Neonatal intensive pain scale during the first 48 hrs of hospital stay

Sponsors and collaborators

Lead sponsor

King Abdullah International Medical Research Center

Other

Registry information

Official study title

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

Acronym: THIN

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 31, 2018
Registry last updated
May 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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