Gel dekstrosa oral untuk mencegah paras glukosa darah rendah dalam neonat yang berisiko
Abstract
Background
Neonatal hypoglycaemia is a common condition that can be associated with brain injury. Current practice usually includes early identification of at‐risk infants (e.g. infants of diabetic mothers; preterm, small‐ or large‐for‐gestational‐age infants), and prophylactic measures are advised. However, these measures often involve use of formula milk or admission to the neonatal unit. Dextrose gel is non‐invasive, inexpensive, and effective for treatment of neonatal hypoglycaemia. Use of prophylactic dextrose gel can prevent neonatal hypoglycaemia, thus potentially reducing separation of mother and baby and supporting breastfeeding, as well as preventing brain injury.
Objectives
To assess the effectiveness and safety of oral dextrose gel in preventing hypoglycaemia among newborn infants at risk of hypoglycaemia and in reducing long‐term neurodevelopmental impairment.
Search methods
We used the standard search strategy of the Cochrane Neonatal Review Group to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 12), MEDLINE via PubMed (1966 to 23 January 2017), Embase (1980 to 23 January 2017), and the Cumulative Index to Nursing and Allied Health Literature (CINAHL; 1982 to 23 January 2017). We also searched clinical trials databases, conference proceedings, and reference lists of retrieved articles for randomised controlled trials and quasi‐randomised trials.
Selection criteria
We included randomised and quasi‐randomised studies comparing dextrose gel versus placebo, no intervention, or other therapies for prevention of neonatal hypoglycaemia.
Data collection and analysis
We used standard methodological procedures as expected by the Cochrane Collaboration. Two review authors independently assessed trial quality and extracted data. We used the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach to assess the quality of evidence.
Main results
We included one trial comparing oral dextrose gel versus placebo in 416 infants at risk of hypoglycaemia. We judged this trial to be at low risk of bias. Using the GRADE method, we determined that evidence ranged from high quality to moderate quality.
For outcomes selected for the GRADE analysis, we found the following.
• Oral dextrose gel prophylaxis (any dose) is associated with reduced risk of neonatal hypoglycaemia compared with placebo (risk ratio (RR) 0.76, 95% confidence interval (CI) 0.62 to 0.94; one RCT; n = 415 infants; high‐quality evidence). The risk difference (RD) is ‐0.13 (95% CI ‐0.23 to ‐0.03), and on average, 8.3 infants would have to receive prophylactic dextrose gel to prevent one additional case of neonatal hypoglycaemia.
• Investigators found no statistically significant differences between dextrose gel and placebo groups in the number of adverse events (RR 1.09, 95% CI 0.55 to 2.17; one RCT; n = 413 infants; moderate‐quality evidence); separation from mother for treatment of hypoglycaemia (RR 0.46, 95% CI 0.21 to 1.01; one RCT, n = 415 infants; moderate‐quality evidence); exclusive breastfeeding at discharge (RR 1.00, 95% CI 0.86 to 1.15; one RCT; n = 415 women; moderate‐quality evidence); or breastfeeding at six weeks postpartum (RR 1.06, 95% CI 0.88 to 1.29; one RCT; n = 386 women; moderate‐quality evidence).
• Researchers provided no data for the other prespecified GRADE outcomes for this review (major neurological disability at two years of age or older; receipt of treatment for hypoglycaemia during initial hospital stay; receipt of intravenous treatment for hypoglycaemia).
Authors' conclusions
Oral dextrose gel reduced the risk of neonatal hypoglycaemia in at‐risk infants in a single trial. Results showed no statistically significant differences in the number of adverse events or in risk of separation of infant from mother for treatment of hypoglycaemia between babies who received oral dextrose gel and those given placebo. Caution is suggested in interpreting data for the latter two outcomes owing to low event rates.
Available evidence is limited to a cohort of at‐risk infants, most of whom were infants of diabetic mothers and were treated on the postnatal ward. Minimal data available for many of the prespecified outcomes of this review showed no long‐term neurodevelopmental and disability outcomes. Additional evidence is needed to assess the efficacy and safety of dextrose gel for prevention of neonatal hypoglycaemia.
PICO
Plain language summary
Gel dekstrosa oral untuk mencegah paras glukosa darah rendah dalam bayi baru lahir
Apakah isunya?
Paras glukosa darah yang rendah adalah lazim dalam kalangan bayi baru lahir. Sehingga 15 dari setiap 100 bayi akan mempunyai paras glukosa darah rendah, dan dalam kalangan sesetengah bayi yang berisiko tinggi (bayi yang lahir pramatang, atau lebih kecil atau lebih besar daripada kebanyakan bayi lain, atau ibu yang menghidap diabetes), sebanyak separuh akan mempunyai paras glukosa darah rendah beberapa hari pertama selepas lahir.
Mengapakah ini penting?
Paras glukosa darah rendah boleh menyebabkan masalah dalam pencapaian akademik dan perkembangan semasa zaman kanak‐kanak. Adalah mungkin hanya satu paras rendah cukup untuk menyumbang kepada masalah‐masalah ini dalam sesetengah bayi. Oleh itu, pencegahan paras glukosa darah rendah adalah berfaedah. Tambahan pula, rawatan untuk paras glukosa darah rendah sering melibatkan susu formula atau kemasukan ke unit neonatal, menyebabkan pemisahan antara ibu dan bayi, dan kedua‐dua pendekatan ini boleh mengganggu penyusuan susu ibu.
Apakah bukti yang kami perolehi?
Semasa carian kemaskini sehingga Januari 2017, kami mendapati satu kajian (dengan risiko bias rendah) yang membandingkan gel dekstrosa oral dengan plasebo untuk pencegahan paras glukosa darah rendah dalam 415 bayi yang berisiko. Bukti daripada kajian tunggal ini menunjukkan dalam bayi yang berisiko, gel dekstrosa oral diikuti oleh susuan dikaitkan dengan pengurangan risiko paras glukosa darah rendah berbanding plasebo (bukti berkualiti tinggi). Keputusan menunjukkan tiada perbezaan yang signifikan secara statistik di antara gel dekstrosa oral dan plasebo dari segi peristiwa buruk (bukti berkualiti sederhana), risiko pemisahan bayi dari ibu untuk rawatan paras glukosa rendah (bukti berkualiti sederhana), penyusuan susu ibu eksklusif semasa discaj (bukti berkualiti sederhana), atau penerusan penyusuan susu ibu pada usia enam minggu (bukti berkualiti sederhana). Kami mesti berhati‐hati ketika mentafsirkan bukti bagi peristiwa buruk dan pemisahan antara ibu dan bayi, kerana sebilangan kecil peristiwa telah dilaporkan bagi hasil‐hasil ini. Para penyelidik tidak memberi data mengenai hasil jangka panjang termasuklah hasil perkembangan dan ketidakupayaan.
Apakah maksudnya?
Bukti sedia ada hanyalah dari satu kajian, dan tiada data hasil jangka panjang dilaporkan. Tambahan pula, kajian ini hanya membandingkan gel dekstrosa oral dengan plasebo dan tidak mengambil kira langkah‐langkah lain yang berpotensi mencegah hipoglisemia. Oleh itu, pada masa kini, tiada cukup bukti untuk menyokong penggunaan rutin gel dekstrosa oral bagi mencegah hipoglisemia dalam bayi baru lahir yang berisiko. Susulan zaman kanak‐kanak bagi kajian tunggal yang dimasukkan ini sedang dijalankan, dan satu kajian tambahan sedang berlansung untuk menentukan kesan gel dekstrosa oral dalam mencegah kemasukan ke unit rawatan rapi neonatal (NICU). Kami menasihatkan untuk menunggu data hasil kajian‐kajian tambahan ini untuk menilai keselamatan jangka panjang dan keberkesanan gel dekstrosa oral bagi pencegahan hipoglisemia neonatal
