OBJECTIVE: Extremely low birth weight infants have a high risk of developing nosocomial bacterial sepsis (NBS). Immature fragile skin may represent an inadequate protective barrier to bacteria colonizing the skin. We conducted a randomized, multicenter trial to determine whether prophylactic application of an emollient ointment would result in a lower incidence of death and/or NBS in the first 28 days of life, compared with routine skin care. METHODS:Infants of birth weight 501 to 1000 g and gestational age < or =30 weeks were assigned randomly to receive generalized application of ointment twice a day through day 14 (prophylactic group [P]) or local application of ointment to the site of injury (routine skin care [R]). The study was conducted at 53 neonatal intensive care units that were members of the Vermont Oxford Network. RESULTS: Included in the analysis were 1191 infants (P: 602; R: 589). No difference was found in the combined primary outcome of NBS or death (33.6% P vs 30.3% R; relative risk [RR]: 1.10; 95% confidence interval [CI]: 0.89, 1.27). The incidence of death was no different between the groups (10.8% P vs 12.1% R; RR: 0.87; 95% CI: 0.59, 1.25). More infants in the prophylactic group had NBS (25.8% P vs 20.4% R; RR: 1.26; 95% CI: 1.02, 1.54), predominantly in the lower birth weight infants (501-750 g) and for infections caused by coagulase-negative staphylococci. Infants in the prophylactic group had better skin condition on days 1 to 14 of life and less skin injury on days 15 to 28 of life. There was no difference between groups in other complications of prematurity. CONCLUSIONS: Prophylactic application of ointment did not lead to a difference in death and/or NBS in the first 28 days of life. There may be an increase in the risk of NBS associated with this practice.
RCT Entities:
OBJECTIVE: Extremely low birth weight infants have a high risk of developing nosocomial bacterial sepsis (NBS). Immature fragile skin may represent an inadequate protective barrier to bacteria colonizing the skin. We conducted a randomized, multicenter trial to determine whether prophylactic application of an emollient ointment would result in a lower incidence of death and/or NBS in the first 28 days of life, compared with routine skin care. METHODS:Infants of birth weight 501 to 1000 g and gestational age < or =30 weeks were assigned randomly to receive generalized application of ointment twice a day through day 14 (prophylactic group [P]) or local application of ointment to the site of injury (routine skin care [R]). The study was conducted at 53 neonatal intensive care units that were members of the Vermont Oxford Network. RESULTS: Included in the analysis were 1191 infants (P: 602; R: 589). No difference was found in the combined primary outcome of NBS or death (33.6% P vs 30.3% R; relative risk [RR]: 1.10; 95% confidence interval [CI]: 0.89, 1.27). The incidence of death was no different between the groups (10.8% P vs 12.1% R; RR: 0.87; 95% CI: 0.59, 1.25). More infants in the prophylactic group had NBS (25.8% P vs 20.4% R; RR: 1.26; 95% CI: 1.02, 1.54), predominantly in the lower birth weight infants (501-750 g) and for infections caused by coagulase-negative staphylococci. Infants in the prophylactic group had better skin condition on days 1 to 14 of life and less skin injury on days 15 to 28 of life. There was no difference between groups in other complications of prematurity. CONCLUSIONS: Prophylactic application of ointment did not lead to a difference in death and/or NBS in the first 28 days of life. There may be an increase in the risk of NBS associated with this practice.
Authors: Karen L Kotloff; Debbie-Ann T Shirley; C Buddy Creech; Sharon E Frey; Christopher J Harrison; Mary Staat; Evan J Anderson; Susan Dulkerian; Isaac P Thomsen; Mohamad Al-Hosni; Barbara A Pahud; David I Bernstein; Jumi Yi; Joshua E Petrikin; Beth Haberman; Kathy Stephens; Ina Stephens; Randolph E Oler; Tom M Conrad Journal: Pediatrics Date: 2019-01 Impact factor: 7.124
Authors: Laurent Renesme; A Allen; F Audeoud; C Bouvard; A Brandicourt; C Casper; L Cayemaex; H Denoual; M A Duboz; A Evrard; C Fichtner; C J Fischer-Fumeaux; L Girard; F Gonnaud; D Haumont; P Hüppi; N Knezovic; E Laprugne-Garcia; S Legouais; F Mons; V Pelofy; J C Picaud; V Pierrat; P Pladys; A Reynaud; G Souet; G Thiriez; P Tourneux; M Touzet; P Truffert; C Zaoui; E Zana-Taieb; C Zores; J Sizun; P Kuhn Journal: Eur J Pediatr Date: 2019-08-28 Impact factor: 3.183
Authors: Rían Hayes; Jack Hartnett; Gergana Semova; Cian Murray; Katherine Murphy; Leah Carroll; Helena Plapp; Louise Hession; Jonathan O'Toole; Danielle McCollum; Edna Roche; Elinor Jenkins; David Mockler; Tim Hurley; Matthew McGovern; John Allen; Judith Meehan; Frans B Plötz; Tobias Strunk; Willem P de Boode; Richard Polin; James L Wynn; Marina Degtyareva; Helmut Küster; Jan Janota; Eric Giannoni; Luregn J Schlapbach; Fleur M Keij; Irwin K M Reiss; Joseph Bliss; Joyce M Koenig; Mark A Turner; Christopher Gale; Eleanor J Molloy Journal: Pediatr Res Date: 2021-11-06 Impact factor: 3.756