Is Early Preventive Caffeine Safe and Effective in Premature Neonates? A Clinical Trial.

Background: Advantages of caffeine for the treatment of apnea of prematurity (AOP) have prompted clinicians to use it as a preventive drug even before the occurrence of apnea. Objective: To compare the effect of early preventive caffeine therapy with routine late preventive caffeine on the occurrence rate of apnea of prematurity, bronchopulmonary dysplasia (BPD) and related radiographic changes, necrotizing enterocolitis (NEC), intraventricular hemorrhage (IVH), and patent ductus arteriosus (PDA), the need for mechanical ventilation, the length of mechanical ventilation, and the length of hospitalization. Materials and Methods: In this open randomized clinical trial study, 90 preterm neonates with the gestational age of 25-35 weeks were divided into 2 groups: group A received caffeine during the first two days of life (early preventive caffeine), while group B received caffeine during the third to the tenth day of life (late preventive caffeine). The occurrence rate of AOP and other outcomes were the primary outcomes. The adverse effects of caffeine in each group were the secondary outcomes. Results: The total occurrence rate of AOP was significantly higher (32.6%) in the late group versus (6.8%) in the early group (p = 0.002). The total occurrence rate of BPD was also significantly higher (37%) in the late group versus (18.2%) in the early group (p = 0.047). On the other hand, we found a lower need for mechanical ventilation, shorter length of mechanical ventilation, shorter length of hospitalization, and a lower occurrence rate of PDA, NEC, and IVH in the early group that was not significant. No adverse effect of caffeine was observed in each group. Conclusions: Early preventive caffeine administration was associated with a significantly lower occurrence rate of AOP, BPD, and BPD radiologic changes. As other outcomes occurred lesser in the early group that were not significant, future studies with more participants are recommended. This study has been registered at the Iranian Registry of Clinical Trials (IRCT20160827029535N8).

The Safety and Efficacy of Lansoprazole plus Metoclopramide among Neonates with Gastroesophageal Reflux Disease Resistant to Conservative Therapy and Monotherapy: A Clinical Trial.

BACKGROUND: Gastroesophageal reflux disease (GERD) is one of the most common problems in neonates. The main clinical manifestations of neonatal GERD are frequent regurgitation or vomiting associated with irritability, crying, anorexia or feeding refusal, failure to thrive, arching of the back, and sleep disturbance. AIMS: The efficacy and safety of ranitidine plus metoclopramide and lansoprazole plus metoclopramide in reducing clinical GERD symptoms based on I-GERQ-R scores in neonatal GERD resistant to conservative and monotherapy. Study Design. This study was a randomized clinical trial of term neonates with GERD diagnosis (according to the final version of the I-GERQ-R), resistant to conservative and monotherapy admitted to Bahrami Children Hospital during 2017-2019. Totally, 120 term neonates (mean age 10.91 ± 7.17 days; girls 54.63%) were randomly assigned to a double-blind trial with either oral ranitidine plus metoclopramide (group A) or oral lansoprazole plus metoclopramide (group B). The changes of the symptoms and signs were recorded after one week and one month. At the end, fifty-four neonates in each group completed the study and their data were analyzed. RESULTS: There was no significant difference in demographic and baseline characteristics between the two groups. The response rate of "lansoprazole plus metoclopramide" was significantly higher than "ranitidine plus metoclopramide" (7.44 ± 3.86 score vs. 9.3 ± 4.57 score, p = 0.018) after one week and (2.41 ± 3.06 score vs. 4.5 ± 4.12 score, p = 0.003) after one month (primary outcome). There were no drug adverse effects in either group during intervention (secondary outcome). CONCLUSIONS: The response rate was significant in each group after one week and one month of treatment, but it was significantly higher in the "lansoprazole plus metoclopramide" group compared with the "ranitidine plus metoclopramide" group. The combination of each acid suppressant with metoclopramide led to a higher response rate in comparison with monotherapy used before intervention. This study has been registered at the Iranian Registry of Clinical Trails (RCT20160827029535N3).

Sacrococcygeal pilonidal sinus treated by a new fascio-cutaneous flap.

PURPOSE: This study reported the technical details and preliminary clinical outcomes of a new fascio-cutaneous transposition flap for the surgical treatment of pilonidal sinus. METHODS: Fifty-two patients with pilonidal sinus were surgically treated. During the surgical procedure, an inferiorly pedicled, fascio-cutaneous flap with specific geometric characteristics was prepared and transposed. Postoperative pain, complications, duration of hospital stay, and time off worked were assessed. Patients were followed for eighteen months after surgery. RESULTS: The mean hospital stay was 2 days. Drains and sutures were removed after 3 and 12 days, respectively. No flap ischemia, wound dehiscence or major complications were observed. Tension on suture lines and pain after surgery were negligible. Wound infections occurred in 4 patients (7.7 percent) and were managed by removing a few sutures. Seroma was detected in 6 patients (11.5 percent). The mean time patients missed work was 7 days. No recurrence was observed during the follow-up period of 18 months. CONCLUSIONS: With no disease recurrence, minimal complication rate, time off work, and acceptable aesthetic outcome, this fascio-cutaneous transposition flap technique is a safe and effective method for surgically treating pilonidal sinus.

The effect of a short course of moderate pressure sunflower oil massage on the weight gain velocity and length of NICU stay in preterm infants.

OBJECTIVE: The aim of this study was to evaluate the efficacy of five-day course of sunflower oil massage with moderate pressure on the weight gain and length of NICU stay in preterm infants. METHODS: Forty-four healthy preterm infants with a corrected gestational age of 30-36 weeks at the time of the study, were randomly assigned to the study group receiving body massage with sunflower oil and the control group receiving only routine NICU care. The massage was performed three times per day, each session including three consecutive five-minute stages, for five days. The primary outcome was to evaluate the efficacy of a short course of moderate pressure sunflower oil massage on the weight gain velocity. The secondary outcome was to compare the length of NICU stay between the two groups. RESULTS: During the study period, the increase in the average daily and fifth-day weight gain was significant in the intervention group. The length of NICU stay was shorter in the intervention group significantly. CONCLUSION: Our findings suggest that even a short course of body massage with sunflower oil for only five days increases preterm infants' weight gain and decreases their duration of NICU stay significantly.

Is ceftizoxime an appropriate surrogate for amikacin in neonatal sepsis treatment? A randomized clinical trial.

Neonatal sepsis, a life-threatening condition, presents with non-specific clinical manifestations and needs immediate empirical antimicrobial therapy. Choosing an appropriate antibiotic regimen covering the most probable pathogens is an important issue. In this study we compared the effectiveness of ceftizoxime and amikacin in the treatment of neonatal sepsis both in combination with ampicillin. In a randomized clinical trial, all term neonates with suspected sepsis referred to Bahrami hospital during March 2008 to March 2010 were evaluated. Patients were randomly recruited into two groups; one group receiving ampicillin and amikacin and the other ampicillin and ceftizoxime. Blood, urine and cerebrospinal fluid cultures, leukocyte count and C-reactive protein level were measured in all neonates. A total of 135 neonates were evaluated, 65 in amikacin group and 70 in ceftizoxime group. 60 neonates (85.7%) in ceftizoxime group and 54 neonates (83.1%) in amikacin group responded to the treatment (P= 0.673 and χ2 = 0.178). Only 24 (18%) blood samples had a report of positive blood culture. The most frequent pathogen was coagulase negative staphylococcus with the frequency of 58.32% of all positive blood samples. Ceftizoxime in combination with ampicillin is an appropriate antimicrobial regimen for surrogating the combination of ampicillin and amikacin to prevent bacterial resistance against them.