2% chlorhexidine-70% isopropyl alcohol versus 10% povidone-iodine for insertion site cleaning before central line insertion in preterm infants: a randomised trial.

OBJECTIVE: To determine whether 2% chlorhexidine gluconate-70% isopropyl alcohol (CHX-IA) is superior to 10% aqueous povidone-iodine (PI) in preventing catheter-related blood stream infection (CR-BSI) when used to clean insertion sites before placing central venous catheters (CVCs) in preterm infants. DESIGN: Randomised controlled trial. SETTING: Two neonatal intensive care units (NICUs). PATIENTS: Infants <31 weeks' gestation who had a CVC inserted. INTERVENTIONS: Insertion site was cleaned with CHX-IA or PI. Caregivers were not masked to group assignment. MAIN OUTCOME MEASURES: Primary outcome was CR-BSI determined by one microbiologist who was masked to group assignment. Secondary outcomes included skin reactions to study solution and thyroid dysfunction. RESULTS: We enrolled 304 infants (CHX-IA 148 vs PI 156) in whom 815 CVCs (CHX-IA 384 vs PI 431) were inserted and remained in situ for 3078 (CHX-IA 1465 vs PI 1613) days. We found no differences between the groups in the proportion of infants with CR-BSI (CHX-IA 7% vs PI 5%, p=0.631), the proportion of CVCs complicated by CR-BSI or the rate of CR-BSI per 1000 catheter days. Skin reaction rates were low (<1% CVC insertion episodes) and not different between the groups. More infants in the PI group had raised thyroid-stimulating hormone levels and were treated with thyroxine (CHX-IA 0% vs PI 5%, p=0.003). CONCLUSIONS: We did not find a difference in the rate of CR-BSI between preterm infants treated with CHX-IA and PI, and more infants treated with PI had thyroid dysfunction. However, our study was not adequately powered to detect a difference in our primary outcome and a larger trial is required to confirm our findings. TRIAL REGISTRATION: This study was registered with the EU clinical trials register before the first patient was enrolled (Eudract 2011-002962-19). (https://www.clinicaltrialsregister.eu).

A randomized trial of exothermic mattresses for preterm newborns in polyethylene bags.

BACKGROUND AND OBJECTIVE: Hypothermia on admission to the NICU is associated with increased mortality in preterm infants. Many newborns are hypothermic on admission despite using polyethylene bags (PBs). Using exothermic mattresses (EMs) in addition to PBs may reduce hypothermia but increase hyperthermia. We wished to determine whether placing preterm newborns in PBs on EMs in the DR results in more infants with rectal temperature outside the range 36.5 to 37.5°C on NICU admission. METHODS: Infants <31 weeks were randomly assigned before birth to treatment with or without an EM. All infants were placed in a PB and under radiant heat immediately after birth and brought to NICU in a transport incubator. Infants randomly assigned to EM were placed on a mattress immediately after delivery and remained on it until admission. Randomization was stratified by gestational age. Rectal temperature was measured with a digital thermometer on NICU admission. RESULTS: The data safety monitoring committee recommended stopping for efficacy after analyzing data from half the planned sample. We report data for 72 infants enrolled at this time. Fewer infants in PBs on EMs had temperatures within the target range (15/37 [41%] vs 27/35 [77%], P = .002) and more had temperatures >37.5°C (17/37 [46%] vs 6/35 [17%], P = .009). CONCLUSIONS: In very preterm newborns, using EMs in addition to PBs in the DR resulted in more infants with temperatures outside the normal range and more hyperthermia on NICU admission.

A randomized trial of nasal prong or face mask for respiratory support for preterm newborns.

BACKGROUND AND OBJECTIVE: Resuscitation guidelines recommend that respiratory support should be given to newborns via a face mask (FM) in the delivery room (DR). Respiratory support given to preterm newborns via a single nasal prong (SNP; ie, short nasal tube, nasopharyngeal tube) may be more effective. We wished to determine whether giving respiratory support to preterm newborns with a SNP rather than a FM reduces the rate of intubation in the DR. METHODS: Infants <31 weeks' gestation were randomized just before delivery to SNP (endotracheal tube shortened to 5 cm) or FM. Randomization was stratified by gestation (<28 weeks, 28-30(+6)). Infants with apnea, respiratory distress, and/or heart rate <100 received positive pressure ventilation with a T-piece. The primary outcome was intubation and mechanical ventilation in the DR. Infants in both groups were intubated for heart rate <100 and/or apnea despite PPV and not solely for surfactant administration. All other aspects of treatment in the DR and NICU were the same. Relevant secondary outcomes were recorded and data were analyzed by using the intention-to-treat principle. RESULTS: One hundred forty-four infants were enrolled. The rate of intubation in the DR was the same in both groups (11/72 [15%] vs 11/72 [15%], P = 1.000]. Infants assigned to SNP had lower SpO2 at 5 minutes and received a higher maximum concentration of oxygen in the DR. There were no significant differences in other secondary outcomes. CONCLUSIONS: Giving respiratory support to newborn infants <31 weeks' gestation via a SNP, compared with a FM, did not result in less intubation and ventilation in the DR.

Randomized trial of prongs or mask for nasal continuous positive airway pressure in preterm infants.

OBJECTIVE: To determine whether nasal continuous positive airway pressure (NCPAP) given with nasal prongs compared with nasal mask reduces the rate of intubation and mechanical ventilation in preterm infants within 72 hours of starting therapy. METHODS: Infants <31 weeks' gestation treated with NCPAP were randomly assigned to receive it via either prongs or mask. Randomization was stratified by gestational age (<28 weeks, 28-30 weeks) and according to whether NCPAP was started as a primary treatment for respiratory distress or postextubation. Infants were intubated and ventilated if they fulfilled 2 or more of 5 failure criteria (worsening signs of respiratory distress; recurrent apnea treated with mask positive pressure ventilation; fraction of inspired oxygen >0.4 to keep oxygen saturation >88% sustained for 30 minutes; pH <7.2 on 2 blood gases ≥ 30 minutes apart; Pco(2) >9 kPa [68 mm Hg] on 2 blood gases ≥ 30 minutes apart) within 72 hours of starting therapy. The groups were treated the same in all other respects. We recorded relevant secondary outcomes and analyzed data by using the intention-to-treat principle. RESULTS: We enrolled 120 infants. Thirty-two of 62 (52%) infants randomly assigned to prongs were intubated within 72 hours, compared with 16/58 (28%) of those randomly assigned to mask (P = .007). There were no statistically significant differences between the groups in any secondary outcomes. CONCLUSIONS: In premature infants, NCPAP was more effective at preventing intubation and ventilation within 72 hours of starting therapy when given via nasal masks compared with nasal prongs.