Clinical trial NCT04422041: Comparison of Early Versus Very Early Postnatal Discharge on Hospital Readmissions in Newborns
Official title: Comparison of Early Versus Very Early Postnatal Discharge on Hospital Readmissions in Newborns: A Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hospital Readmission
Newborn Morbidity
Newborn Complication
Newborn
Keywords: Newborn Infant
Hospital readmission
Early discharge
Very early discharge
Lead sponsor: Universidad Autonoma de Nuevo Leon
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 354
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: They were selected based on a random computer program in a 1: 1 model, assigning each subject randomly to one of the two study groups
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study compared hospital readmission and complications between very early discharge and early discharge in healthy newborn patients.

Detailed description: Introduction. Very early postnatal discharge is defined as a hospital stay of the mother-child dyad of less than 24 hours. It is usually performed in public institutions of low-income countries due to high birth rates; it has not been associated to a higher proportion of neonatal admissions, however, very early discharge might increase this risk. The objective of this study was to compare the rate hospital readmission in patients with very early vs early postnatal discharge.

Methods A prospective, randomized clinical study was performed with healthy term infants born in a hospital in Mexico from July 2016 to June 2018. Sample was randomized into two groups, a very early discharge group (\<24 hours) and an early discharge group (24-48 hours). Hospital readmission rate was analyzed in both groups.

Eligibility criteria: Inclusion Criteria:

* Healthy newborns that were born from vaginal delivery in primiparous or multiparous women where both the mother and the newborn were deemed as eligible for early discharge according to the American Association of Pediatrics criteria and by a clinical obstetric mother evaluation.

Exclusion Criteria:

* Placenta praevia, abnormal bleeding during vaginal delivery (considered as greater than 500mL), inhability to deambulate, medical complications from previous a previous pregnancy, 3rd or 4th degree perineal laceration as well as medical conditions that required any monitorization for more than 24 hours after delivery.

Primary outcomes:
measure: Hospital readmission rate
timeFrame: 28 days
Secondary outcomes:
measure: Rate of attention in emergency services
timeFrame: 28 days
measure: Readmission rate associated factors
timeFrame: 28 days
Other outcomes:
Locations:
Study officials:
affiliation: Universidad Autonoma de Nuevo Leon, School of Medicine, Department of Pediatrics
name: Erika Ochoa-Correa, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jones E, Taylor B, MacArthur C, Pritchett R, Cummins C. The effect of early postnatal discharge from hospital for women and infants: a systematic review protocol. Syst Rev. 2016 Feb 8;5:24. doi: 10.1186/s13643-016-0193-9.
citation: Brown S, Small R, Faber B, Krastev A, Davis P. Early postnatal discharge from hospital for healthy mothers and term infants. Cochrane Database Syst Rev. 2002;(3):CD002958. doi: 10.1002/14651858.CD002958.
citation: Benitz WE; Committee on Fetus and Newborn, American Academy of Pediatrics. Hospital stay for healthy term newborn infants. Pediatrics. 2015 May;135(5):948-53. doi: 10.1542/peds.2015-0699.
citation: Chalmers B, Mangiaterra V, Porter R. WHO principles of perinatal care: the essential antenatal, perinatal, and postpartum care course. Birth. 2001 Sep;28(3):202-7. doi: 10.1046/j.1523-536x.2001.00202.x.
citation: Capurro H, Konichezky S, Fonseca D, Caldeyro-Barcia R. A simplified method for diagnosis of gestational age in the newborn infant. J Pediatr. 1978 Jul;93(1):120-2. doi: 10.1016/s0022-3476(78)80621-0. No abstract available.
citation: SILVERMAN WA, ANDERSEN DH. A controlled clinical trial of effects of water mist on obstructive respiratory signs, death rate and necropsy findings among premature infants. Pediatrics. 1956 Jan;17(1):1-10. No abstract available.