Effect of reducing caffeine intake on birth weight and length of gestation: randomised controlled trial. Caffeine citrate for the treatment of apnea of prematurity: a double-blind, placebo-controlled study. A randomized controlled trial of smoking cessation intervention in pregnancy in an academic clinic. The efficacy of caffeine in the treatment of recurrent idiopathic apnea in premature infants. A randomized controlled trial of a smoking cessation intervention during pregnancy. Multimodal intervention raises smoking cessation rate during pregnancy. High-dose caffeine suppresses postoperative apnea in former preterm infants. Efficacy and effectiveness of the smoking cessation program for pregnant women. Does caffeine prevent hypoxaemic episodes in premature infants? A randomized controlled trial.
To estimate the effect of reducing caffeine intake during pregnancy on birth weight and length of gestation.
                Randomised double blind controlled trial.
                Denmark.
                1207 pregnant women drinking at least three cups of coffee a day, recruited before 20 weeks' gestation.
                Caffeinated instant coffee (568 women) or decaffeinated instant coffee (629 women).
                Birth weight and length of gestation.
                Data on birth weight were obtained for 1150 liveborn singletons and on length of gestation for 1153 liveborn singletons. No significant differences were found for mean birth weight or mean length of gestation between women in the decaffeinated coffee group (whose mean caffeine intake was 182 mg lower than that of the other group) and women in the caffeinated coffee group. After adjustment for length of gestation, parity, prepregnancy body mass index, and smoking at entry to the study the mean birth weight of babies born to women in the decaffeinated group was 16 g (95% confidence interval -40 to 73) higher than those born to women in the caffeinated group. The adjusted difference (decaffeinated group-caffeinated group) of length of gestation was -1.31 days (-2.87 to 0.25).
                A moderate reduction in caffeine intake in the second half of pregnancy has no effect on birth weight or length of gestation.
                Clinical Trials NCT00131690 [ClinicalTrials.gov]. To evaluate the efficacy and safety of caffeine citrate for treatment of apnea of prematurity.
                Multicenter, parallel, randomized, double-blind, placebo-controlled trial with open-label rescue.
                Nine neonatal intensive care units.
                Eighty-five infants, 28-32 weeks postconception and 24 hours or more after birth who had six or more apnea episodes within 24 hours.
                Caffeine citrate 10 mg/kg (as caffeine base) administered intravenously, followed by 2.5 mg/kg/day orally or intravenously, or placebo, for up to 10 days. Infants failing double-blind therapy could receive open-label rescue.
                Success was defined as 50% or greater reduction in apnea episodes and elimination of apnea. Caffeine citrate was significantly more effective than placebo in reducing apnea episodes by at least 50% in 6 days (p<0.05), and approached statistical significance (p<0.10) in 3 days. It was significantly better than placebo in eliminating apnea in 5 days (p<0.05), and approached significance (p<0.10) in 2 days. The number of infants with an aggregate of 7-10 days of at least a 50% reduction in apnea events or elimination of apnea was significantly higher in the caffeine citrate than in the placebo group. Adverse events did not differ significantly between groups. No correlations were found between success and mean daily plasma concentrations or baseline characteristics. Volume of distribution and clearance increased with weight, supporting weight-adjusted dosing of caffeine citrate.
                Caffeine citrate 10 mg/kg caffeine base (equivalent to 20 mg/kg caffeine citrate) intravenously followed by 2.5 mg/kg/day caffeine base (equivalent to 5 mg/kg/day caffeine citrate) either intravenously or orally for 10 days is safe and effective for treating apnea of prematurity in infants 28-32 weeks postconception. To evaluate the effectiveness of a physician-based intervention to promote smoking cessation during pregnancy, we conducted this randomized controlled trial in the resident-staffed prenatal clinics at the University of North Carolina Women's Hospital . Two hundred fifty prenatal patients who smoked were enrolled at their first visit and randomly assigned to the intervention or the usual-care group. Resident physicians provided self-help materials to intervention subjects and used a script to set goals with them at each prenatal visit. Subjects who set quit dates were contacted by volunteer cessation counselors. To verify smoking status, subjects provided a self-report and breath carbon monoxide (CO) sample at each visit. Controls were similarly assessed at enrollment and at three additional predetermined intervals. Twenty percent of intervention subjects and 10% of controls reported cessation, which was verified by CO level (P = .052). Fifty-one percent of subjects reduced their consumption by half or more, compared with 30% of controls (P = .002). The intervention is effective in promoting smoking cessation and reduction. In addition, this technique is inexpensive, readily accepted by staff, and efficient. This prospective controlled study was aimed at evaluating the efficacy of caffeine in treating recurrent idiopathic apnea in the premature infant. Eighteen preterm infants (29 to 35 weeks' gestation) were studied. Recordings during the first 24 hours and on the fifth day of caffeine treatment showed a significant decrease of severe apnea (P less than 0.01) and of mild apnea (P less than 0.001) in the treated group (group 1) as compared with the control group (group II). No treatment of apnea other than caffeine was required in group I, whereas six neonates in group II had such severe and frequent apneic episodes for more than 48 hours that withholding additional treatment was believed to be unethical. No undesirable side effects of caffeine treatment were observed. This study was a randomized controlled trial of a smoking cessation intervention for pregnant smokers. Women who reported smoking at their first antenatal visit and satisfied the inclusion criteria were asked to participate in the trial. Analysis was restricted to 393 evaluable women in the control group (received usual antenatal care) and 339 women to the study group (received usual antenatal care plus the intervention). The primary hypotheses were that the intervention would result in a higher proportion of quitters and that the mean birth-weight of babies born to women receiving the intervention would be greater than that of babies born to women in the control group. The outcome measures were smoking status based on self-report combined with a urinary cotinine level of <115 ng/mL, and birth-weight. There was no significant difference in quit rate between women receiving the intervention and women in the control group (11.9% versus 9.8% p=0.41). Babies born to women receiving the intervention were on average 84 g heavier than babies born to controls (p=0.04). The factors that contribute to the lack of a significant increase in smoking cessation in the intervention group and the possible explanation for the changes in birth-weight are discussed. The aim was to study the effect of a multimodal smoking cessation intervention regimen on a number of pregnant smokers.
                A prospective intervention study was designed where participants were allocated to intervention or control based on their birth date. The study included 647 pregnant smokers. The intervention group (n = 327) received initial individual smoking cessation counseling supplemented by an invitation to join, individually or in a group, a smoking cessation program with nicotine replacement therapy as a voluntary option. Intervention was designed as an integral part of the midwives' prenatal care. All pregnant smokers in the usual care group (n = 320) received standard counseling from a midwife. Outcome was self-reported smoking cessation in the 37th week of pregnancy and the reported cessation was validated by cotinine saliva concentration.
                Self-reported cessation rates during pregnancy were significantly higher in the intervention group (14%) than in the group receiving usual care (5.0%) (p < 0.0001) (Fisher's exact test). Cotinine-validated cessation rates during pregnancy were significantly higher among the former (7%) than the latter (2%) (p = 0.003). The adjusted odds ratio (OR) for smoking cessation was 4.20 (95% CI 2.13-8.03). Logistic regression analysis showed a significant positive association of smoking cessation with low caffeine consumption in pregnancy, many years in school, no exposure to passive smoking outside the home, and previous attempts to stop smoking.
                A multimodal intervention regimen with initial individual counseling supplemented by an invitation to join a smoking cessation program with nicotine replacement therapy as a voluntary option markedly increased cessation rates during pregnancy. Thirty-two former preterm infants (less than or equal to 44 weeks postconceptual age) undergoing inguinal hernia repair were prospectively studied. General inhalational anesthesia with neuromuscular blockade was used. No barbiturates or opioids were given. Infants were randomly divided into two groups. Group 1 received iv caffeine 10 mg/kg immediately after induction of anesthesia. Group 2 received iv saline. Respiratory pattern, heart rate, and SpO2 were monitored using an impedance pneumograph and a pulse oximeter, respectively, for at least 12 h postoperatively. Tracings were analyzed for evidence of apnea, periodic breathing, and/or bradycardia by a pulmonologist unaware of the drug given. None of the patients who received caffeine developed postoperative bradycardia, prolonged apnea, or periodic breathing, and none had postoperative SpO2 less than 90%. In the control group 13 (81%) developed prolonged apnea 4-6 h postoperatively. Fifty percent of the patients had SpO2 less than 90% at the time. This study shows that iv caffeine 10 mg/kg is effective in the control of apnea in otherwise healthy expremature infants between 37 and 44 weeks of postconceptual age. It is still recommended, however, that all infants at risk be monitored for at least 12 h for apnea and bradycardia following general anesthesia. The aim of randomized trial was to evaluate the effectiveness of anti-smoking counseling in the population of pregnant women from the maternity centers in Lódź, central Poland.
                One hundred and forty nine current smokers and 56 spontaneous quitters were randomized into the smoking cessation intervention and 144 current smokers and 37 spontaneous quitters were included in the control group. The intervention program covered four midwife visits during pregnancy and one after delivery. The control units received standard written information about the health risk from maternal smoking to the fetus.
                The chance of quitting smoking by the women was significantly higher in the intervention group than in the control group (OR = 2.5; 95% CI 1.8-3.7). The difference in the mean infant birthweight between the quitters and non-quitters was 203.8 g (p = 0.01) in the intervention group and 198.2 g in the control group (p = 0.08). After controlling for socio-demographic characteristics that could affect the birthweight, the differences remained significant in the intervention group - 182.8 g (p = 0.02), whereas in the control group it was 92.4 g (p = 0.4).
                The midwife-assisted smoking cessation intervention seems to be an effective tool to help pregnant smokers make a decision to quit smoking. Fifty spontaneously breathing, preterm infants 48 h old, of 32 weeks' gestation or less, were assigned randomly to receive caffeine citrate (loading dose 20 mg/kg, maintenance dose 10 mg/kg per day) or a placebo (NaCl 0.9%). The study hypothesis was that caffeine reduces the proportion of infants with recurrent hypoxaemic episodes (decrease in transcutaneous PO2 of 20% within 20 s) from 50% to 25%. Transcutaneous oxygen tension (tcPO2) and heart rate were recorded continuously for 50 h and analysed by computer. The two groups were similar in gestational age, birth weight, delivery mode, sex distribution, and Apgar scores. The mean serum concentration (+/- SD) of caffeine 2 h after the second maintenance dose was 96.0 (+/- 34.5) mumol/l in the group receiving caffeine and 9.3 (+/- 12.8) mumol/l in the group receiving a placebo. The mean proportion of infants with more than six hypoxaemic episodes per 12 h in the caffeine groups was higher (57%) than in the control group (51%). The mean proportion of infants with more than six episodes of bradycardia per 12 h was not statistically different in the caffeine group (79%) from the control group (86%). Our results suggest that prophylactic caffeine has little if any effect on the risk of developing hypoxaemic episodes and bradycardia in small preterm infants and the supposed 50% reduction which was considered clinically important at the start of the trial can be rejected with confidence.
There is insufficient evidence to confirm or refute the effectiveness of caffeine avoidance on birthweight or other pregnancy outcomes. There is a need to conduct high-quality, double-blinded RCTs to determine whether caffeine has any effect on pregnancy outcome.