Hospital ReadmissionNCT04422041
Comparison of Early Versus Very Early Postnatal Discharge on Hospital Readmissions in Newborns
A study testing Time to discharge less than 24 hours and Discharge time between 24 and 48 hours in people with Hospital Readmission and Newborn Morbidity, run by Universidad Autonoma de Nuevo Leon.
Trial summary
This study compared hospital readmission and complications between very early discharge and early discharge in healthy newborn patients. Read more about this study
- Who is it for?
- Ages 1 minute to 2 days
- Conditions the study is for
- Hospital Readmission, Newborn Morbidity, Newborn Complication
- What is being tested?
- Time to discharge less than 24 hours and Discharge time between 24 and 48 hours
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 354 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2016to 29 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 2 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Comparison of Early Versus Very Early Postnatal Discharge on Hospital Readmissions in Newborns: A Prospective Study
This study compared hospital readmission and complications between very early discharge and early discharge in healthy newborn patients.
Read the 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.
- Conditions
- Hospital Readmission, Newborn Morbidity, Newborn Complication, Newborn
- Being tested
- Time to discharge less than 24 hours, Discharge time between 24 and 48 hours
- Keywords
- Newborn Infant, Hospital readmission, Early discharge, Very early discharge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time to discharge less than 24 hoursOther
Allow the joint medical discharge of the newborn together with its mother in less than 24 hours after birth in a healthy patient, without obstetric complications and who does not present comorbidities and complications.
Discharge time between 24 and 48 hoursOther
Allow the joint medical discharge of the newborn together with its mother between 24-48 hours after birth in a healthy patient, without obstetric complications and who does not present comorbidities and complications.
| Study group | Role | What they receive |
|---|---|---|
| Early discharge | Active comparator | Discharge between 24 and 48 hours Receives: Other: Discharge time between 24 and 48 hours |
| Very early discharge | Experimental | Discharge in less than 24 hours Receives: Other: Time to discharge less than 24 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital readmission rate
Proportion of participant newborns who were readmitted into the hospital during follow up
Measured: 28 days
Secondary outcomes (2)
Rate of attention in emergency services
Proportion of participant newborns who attended the emergency services during follow up
Measured: 28 days
Readmission rate associated factors
Statistical associations between the primary outcome and other variables of interest
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 Jul 2016
- Primary completion29 Jun 2018
- Study completion29 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hospital ReadmissionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Nuevo Leon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erika Ochoa-Correa, Universidad Autonoma de Nuevo Leon
- Investigators
- Erika Ochoa-Correa, M.D., Principal investigator, Universidad Autonoma de Nuevo Leon, School of Medicine, Department of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04422041
- Sponsor's protocol ID
- PE15-039
- Status last verified
- Jun 2020
- First submitted
- 4 Jun 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26857705Brown 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.
PubMed 12137666Benitz 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.
PubMed 25917993Chalmers 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.
PubMed 11552969Capurro 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.
PubMed 650322SILVERMAN 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.
PubMed 13353856
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Early Versus Very Early Postnatal Discharge on Hospital Readmissions in Newborns: A Prospective Study
- ClinicalTrials.gov ID
- NCT04422041
- Acronym / sponsor ID
- PE15-039
- Conditions
- Hospital Readmission, Newborn Morbidity, Newborn Complication, Newborn
- Keywords
- Newborn Infant, Hospital readmission, Early discharge, Very early discharge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- Universidad Autonoma de Nuevo LeonUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 29 Jun 2018 (actual)
- Study completion
- 29 Jul 2018 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Early discharge | Active comparator | Other: Discharge time between 24 and 48 hoursDischarge between 24 and 48 hours |
| Very early discharge | Experimental | Other: Time to discharge less than 24 hoursDischarge in less than 24 hours |
Who may qualify
- Ages
- 1 minute to 2 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time to discharge less than 24 hoursAllow the joint medical discharge of the newborn together with its mother in less than 24 hours after birth in a healthy patient, without obstetric complications and who does not present comorbidities and complications. | Other | Very early discharge |
| Discharge time between 24 and 48 hoursAllow the joint medical discharge of the newborn together with its mother between 24-48 hours after birth in a healthy patient, without obstetric complications and who does not present comorbidities and complications. | Other | Early discharge |
Primary outcome
Hospital readmission rate
Time frame: 28 days
Proportion of participant newborns who were readmitted into the hospital during follow up
2 secondary outcomes
Rate of attention in emergency services
Time frame: 28 days
Readmission rate associated factors
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Background: PubMed 26857705Jones 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.
- Background: PubMed 12137666Brown 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.
- Background: PubMed 25917993Benitz 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.
- Background: PubMed 11552969Chalmers 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.
- Background: PubMed 650322Capurro 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.
- Background: PubMed 13353856SILVERMAN 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erika Ochoa-Correa, M.D. principal investigator
Universidad Autonoma de Nuevo Leon, School of Medicine, Department of Pediatrics
Questions about this trial
What is this clinical trial studying?
A study testing Time to discharge less than 24 hours and Discharge time between 24 and 48 hours in people with Hospital Readmission and Newborn Morbidity, run by Universidad Autonoma de Nuevo Leon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital readmission rate (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04422041, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.