HyperbilirubinemiaPhase 3NCT00360204
Improving Health Outcomes for New Mothers and Babies
A Phase 3 study testing Home Nurse Visit in people with Hyperbilirubinemia and Jaundice, run by Milton S. Hershey Medical Center at 2 sites in United States.
Trial summary
Because adherence to postnatal care guidelines across the United States (U.S.) is poor, newborns and mothers often are placed at undue risk for adverse medical and social outcomes. Read more about this study
- Who is it for?
- Ages 1 day to 7 monthsHealthy volunteers can take part
- Conditions the study is for
- Hyperbilirubinemia, Jaundice, Dehydration
- What is being tested?
- Home Nurse Visit
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,154 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2006to Feb 2010
- Phase
- Phase 3
- 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 day to 7 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Full term or late pre-term infant (> 34 0/7 weeks gestational age) discharged from the newborn nursery
- Feeding human milk (breast milk) during the maternity/newborn stay with intent to continue to breastfeed after discharge
- English speaking mother
- Singleton or twin infant
Who cannot join
- Premature infant < 34 weeks gestational age
- Exclusively formula fed infant during nursery stay
- Complicated maternity/nursery stay requiring > 2 night stay after a vaginal delivery or > 4 night stay after a cesarean section
- A nursery course with atypical complications (e.g. a work-up for ambiguous genitalia)
- Infant with hyperbilirubinemia requiring phototherapy during the nursery stay
- Any major maternal morbidities and/or pre-existing condition that would effect postpartum care such as cancer, multiple sclerosis, lupus, etc.
Show all 13Show fewer
- Previous maternal participation in the NITTANY trial
- Residence outside of the coverage area for the Visiting Nurses Association (VNA) of Central Pennsylvania
- Family with no active telephone number (home or cellular)
- Infant being put up for adoption
- Non-English speaking mother
- Family requiring a home visit due to Social Work or other staff request/order
- Triplets or higher order gestation
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Because adherence to postnatal care guidelines across the United States (U.S.) is poor, newborns and mothers often are placed at undue risk for adverse medical and social outcomes. This study aims to evaluate an alternative model of care and improve healthcare delivery to and reduce health disparities for "well" newborns and mothers after hospital discharge by using single postnatal home nurse visits. The principal investigator has previously shown a reduction in poor outcomes for infants who receive a home visit after discharge when studied retrospectively. The proposed research will build on the previous study and prospectively evaluate the impact of a single home nursing visit on morbidities and health disparities for newborns and mothers in a randomized, controlled trial involving 1154 mother/infant breastfeeding dyads. Home visits should guarantee detailed assessment during an at-risk period of infancy and motherhood, where medical and social problems can be recognized, anticipated, and/or treated, and can bridge the gap between hospital care and primary care. The investigators' program, The Nurses for Infants Through Teaching and Assessment after the NurserY (NITTANY) Initiative, also will consider the cost-effectiveness of home visitation compared with guidelines-adherent outpatient clinic care.
Read the detailed description
In the NITTANY Initiative the effectiveness of a single postnatal/postpartum home nurse visit will be evaluated prospectively and compared with outpatient clinic-based care using a randomized, controlled study design. We will attempt to reduce morbidity in the neonatal/postpartum period using a well-timed home visit measured first by a reduction in the need for additional hospital services (inpatient hospitalization and ED visitation) in the first 14 days after delivery. While healthcare utilization may not be the most important health outcome for newborns and mothers from a long-term perspective, the demographic groups at-risk for these outcomes tend to parallel those at greater long-term risk. Also, in the short-term these outcomes may be the most costly ones for insurance providers and can be used in a cost-effectiveness analysis to justify home nurse visits. Readmissions and use of urgent care also may be the most noticeable outcome for clinicians, which should help to modify practice patterns and improve compliance with guidelines for healthcare delivery.
Over a 3-year period we will prospectively enroll a cohort of 1154 "well" singleton newborns and their mothers admitted to the hospital nursery that are most at-risk for readmission based on demographic features. Previous data have indicated those at greatest risk for adverse health outcomes are infants born to breastfeeding mothers and those with less parenting experience. Minorities and Medicaid recipients are more likely to suffer from healthcare disparities. For mothers, morbidities may occur in all socioeconomic groups, but those undergoing operative delivery or instrument assisted vaginal deliveries tend to suffer greater morbidity. In this study, patients will be randomized to receive usual, guideline adherent, post-discharge care with or without a home nurse visit 1-2 days after nursery discharge. For each newborn and mother, information from the pregnancy, obstetrical record, and the nursery course will be collected. Data also will be recorded regarding continuity of care during the perinatal period, hospital readmissions, ED visits, compliance with and extent of outpatient care, satisfaction with and convenience of care, and costs of healthcare. Method of infant feeding, maternal confidence, maternal depression and anxiety, and satisfaction with care will also be assessed.
To accomplish the objectives of this project, we will focus on the following 3 specific aims:
SPECIFIC AIM 1. Establish that single home nursing visits improve healthcare delivery to and reduce adverse health outcomes for breastfeeding newborns.
This model of home visitation will be shown to reduce postnatal morbidities, improve compliance with post-discharge guidelines, and reduce disparities in health outcomes for those enrolled in a prospective trial based on data presented under Preliminary Studies conducted by the PI. A randomized, controlled trial will be conducted over a period of 36 months to demonstrate that infants that receive a single home visit have a reduced need for subsequent hospital-based or non-scheduled urgent care services. Secondary outcomes of importance will include compliance with follow-up guidelines and breastfeeding rates that also are expected to improve in those receiving a home visit.
SPECIFIC AIM 2. Establish that single home nursing visits improve healthcare delivery to and reduce adverse outcomes for mothers who are breastfeeding their newborns. Maternal readmission, emergency department utilization, and need for non-scheduled urgent care services will be reduced in the group of women receiving a single, postpartum home visit compared with standard care. Additionally, parenting sense of competence, satisfaction with postpartum healthcare, level of perceived social support, and the incidence of postpartum depression and anxiety will be improved among women randomized to receive a home nursing visit during the stressful and emotional period following childbirth compared with those randomized to not receive a home visit.
SPECIFIC AIM 3. Prospectively evaluate the cost-effectiveness of a single postnatal home nursing visit after maternity/nursery hospital discharge.
Data from the trial will be used to perform a stochastic cost-effectiveness analysis to demonstrate prospectively that a single home nursing visit is cost-effective based upon the reduction of the need for subsequent hospital or non-scheduled urgent care based services (inpatient, emergency department, and outpatient) for newborns and mothers in the first 14 postnatal/postpartum days. Again based on the previous retrospective study conducted by the PI, home visits are expected to be a cost-effective intervention. Other factors including maternal health outcomes, breastfeeding, and long-term health and social outcomes will be assessed in terms of their relationship with cost.
- Conditions
- Hyperbilirubinemia, Jaundice, Dehydration, Postpartum Depression
- Being tested
- Home Nurse Visit
- Keywords
- Infant health, parenting competence, Home nurse visit, maternal post-partum care, postpartum health utilization, Breastfeeding
- Medical subject headings
- Hyperbilirubinemia, Jaundice, Dehydration, Depression, Postpartum, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Nurse VisitBehavioural
Home nurse visit by maternal child health nurse within first 24-48 after post-partum hospital discharge.
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of unplanned maternal and child healthcare services (inpatient, Emergency Department (ED), urgent/acute care, primary care, and mental health) in the first 14 days after delivery
Measured: 3 years
Secondary outcomes (6)
Adherence to continuity of care guidelines
Measured: 3 years
Postpartum anxiety
Measured: 3 years
Breastfeeding duration
Measured: 3 years
Maternal satisfaction with post-discharge healthcare
Measured: 3.5 years
Parenting sense of competence
Measured: 3.5 years
Cost of care
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2006 (estimated)
- Study startSep 2006
- Primary completionAug 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HyperbilirubinemiaStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services, Health Resources and Services Administration (HRSA), HRSA/Maternal and Child Health Bureau
- Responsible party
- Principal investigator, Ian M. Paul, MD, Milton S. Hershey Medical Center
- Investigators
- Ian M Paul, MD, MSc, Principal investigator, Penn State Milton S. Hershey Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00360204
- Sponsor's protocol ID
- 22163
- Other IDs
- R40 MC 06630-01
- Status last verified
- Jul 2017
- First submitted
- 3 Aug 2006
- Last updated
- 28 Jul 2017
- Results posted
- No
Publications
Hackman NM, Schaefer EW, Beiler JS, Rose CM, Paul IM. Breastfeeding outcome comparison by parity. Breastfeed Med. 2015 Apr;10(3):156-62. doi: 10.1089/bfm.2014.0119. Epub 2014 Dec 30.
PubMed 25549051Paul IM, Downs DS, Schaefer EW, Beiler JS, Weisman CS. Postpartum anxiety and maternal-infant health outcomes. Pediatrics. 2013 Apr;131(4):e1218-24. doi: 10.1542/peds.2012-2147. Epub 2013 Mar 4.
PubMed 23460682Bartok CJ, Schaefer EW, Beiler JS, Paul IM. Role of body mass index and gestational weight gain in breastfeeding outcomes. Breastfeed Med. 2012 Dec;7(6):448-56. doi: 10.1089/bfm.2011.0127. Epub 2012 Jun 25.
PubMed 23215909Paul IM, Beiler JS, Schaefer EW, Hollenbeak CS, Alleman N, Sturgis SA, Yu SM, Camacho FT, Weisman CS. A randomized trial of single home nursing visits vs office-based care after nursery/maternity discharge: the Nurses for Infants Through Teaching and Assessment After the Nursery (NITTANY) Study. Arch Pediatr Adolesc Med. 2012 Mar;166(3):263-70. doi: 10.1001/archpediatrics.2011.198. Epub 2011 Nov 7.
PubMed 22064874
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Health Outcomes for New Mothers and Babies
- ClinicalTrials.gov ID
- NCT00360204
- Acronym / sponsor ID
- 22163
- Conditions
- Hyperbilirubinemia, Jaundice, Dehydration, Postpartum Depression
- Keywords
- Infant health, parenting competence, Home nurse visit, maternal post-partum care, postpartum health utilization, Breastfeeding
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,154 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- Department of Health and Human Services, Health Resources and Services Administration (HRSA), HRSA/Maternal and Child Health Bureau
- Study start
- Sep 2006
- Primary completion
- Aug 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 4 Aug 2006 (estimated)
- 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.
Because adherence to postnatal care guidelines across the United States (U.S.) is poor, newborns and mothers often are placed at undue risk for adverse medical and social outcomes. This study aims to evaluate an alternative model of care and improve healthcare delivery to and reduce health disparities for "well" newborns and mothers after hospital discharge by using single postnatal home nurse visits. The principal investigator has previously shown a reduction in poor outcomes for infants who receive a home visit after discharge when studied retrospectively. The proposed research will build on the previous study and prospectively evaluate the impact of a single home nursing visit on morbidities and health disparities for newborns and mothers in a randomized, controlled trial involving 1154 mother/infant breastfeeding dyads. Home visits should guarantee detailed assessment during an at-risk period of infancy and motherhood, where medical and social problems can be recognized, anticipated, and/or treated, and can bridge the gap between hospital care and primary care. The investigators' program, The Nurses for Infants Through Teaching and Assessment after the NurserY (NITTANY) Initiative, also will consider the cost-effectiveness of home visitation compared with guidelines-adherent outpatient clinic care.
Detailed description
In the NITTANY Initiative the effectiveness of a single postnatal/postpartum home nurse visit will be evaluated prospectively and compared with outpatient clinic-based care using a randomized, controlled study design. We will attempt to reduce morbidity in the neonatal/postpartum period using a well-timed home visit measured first by a reduction in the need for additional hospital services (inpatient hospitalization and ED visitation) in the first 14 days after delivery. While healthcare utilization may not be the most important health outcome for newborns and mothers from a long-term perspective, the demographic groups at-risk for these outcomes tend to parallel those at greater long-term risk. Also, in the short-term these outcomes may be the most costly ones for insurance providers and can be used in a cost-effectiveness analysis to justify home nurse visits. Readmissions and use of urgent care also may be the most noticeable outcome for clinicians, which should help to modify practice patterns and improve compliance with guidelines for healthcare delivery.
Over a 3-year period we will prospectively enroll a cohort of 1154 "well" singleton newborns and their mothers admitted to the hospital nursery that are most at-risk for readmission based on demographic features. Previous data have indicated those at greatest risk for adverse health outcomes are infants born to breastfeeding mothers and those with less parenting experience. Minorities and Medicaid recipients are more likely to suffer from healthcare disparities. For mothers, morbidities may occur in all socioeconomic groups, but those undergoing operative delivery or instrument assisted vaginal deliveries tend to suffer greater morbidity. In this study, patients will be randomized to receive usual, guideline adherent, post-discharge care with or without a home nurse visit 1-2 days after nursery discharge. For each newborn and mother, information from the pregnancy, obstetrical record, and the nursery course will be collected. Data also will be recorded regarding continuity of care during the perinatal period, hospital readmissions, ED visits, compliance with and extent of outpatient care, satisfaction with and convenience of care, and costs of healthcare. Method of infant feeding, maternal confidence, maternal depression and anxiety, and satisfaction with care will also be assessed.
To accomplish the objectives of this project, we will focus on the following 3 specific aims:
SPECIFIC AIM 1. Establish that single home nursing visits improve healthcare delivery to and reduce adverse health outcomes for breastfeeding newborns.
This model of home visitation will be shown to reduce postnatal morbidities, improve compliance with post-discharge guidelines, and reduce disparities in health outcomes for those enrolled in a prospective trial based on data presented under Preliminary Studies conducted by the PI. A randomized, controlled trial will be conducted over a period of 36 months to demonstrate that infants that receive a single home visit have a reduced need for subsequent hospital-based or non-scheduled urgent care services. Secondary outcomes of importance will include compliance with follow-up guidelines and breastfeeding rates that also are expected to improve in those receiving a home visit.
SPECIFIC AIM 2. Establish that single home nursing visits improve healthcare delivery to and reduce adverse outcomes for mothers who are breastfeeding their newborns. Maternal readmission, emergency department utilization, and need for non-scheduled urgent care services will be reduced in the group of women receiving a single, postpartum home visit compared with standard care. Additionally, parenting sense of competence, satisfaction with postpartum healthcare, level of perceived social support, and the incidence of postpartum depression and anxiety will be improved among women randomized to receive a home nursing visit during the stressful and emotional period following childbirth compared with those randomized to not receive a home visit.
SPECIFIC AIM 3. Prospectively evaluate the cost-effectiveness of a single postnatal home nursing visit after maternity/nursery hospital discharge.
Data from the trial will be used to perform a stochastic cost-effectiveness analysis to demonstrate prospectively that a single home nursing visit is cost-effective based upon the reduction of the need for subsequent hospital or non-scheduled urgent care based services (inpatient, emergency department, and outpatient) for newborns and mothers in the first 14 postnatal/postpartum days. Again based on the previous retrospective study conducted by the PI, home visits are expected to be a cost-effective intervention. Other factors including maternal health outcomes, breastfeeding, and long-term health and social outcomes will be assessed in terms of their relationship with cost.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 1 day to 7 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Full term or late pre-term infant (> 34 0/7 weeks gestational age) discharged from the newborn nursery
- Feeding human milk (breast milk) during the maternity/newborn stay with intent to continue to breastfeed after discharge
- English speaking mother
- Singleton or twin infant
Key exclusion criteria (13 listed)
- Premature infant < 34 weeks gestational age
- Exclusively formula fed infant during nursery stay
- Complicated maternity/nursery stay requiring > 2 night stay after a vaginal delivery or > 4 night stay after a cesarean section
- A nursery course with atypical complications (e.g. a work-up for ambiguous genitalia)
- Infant with hyperbilirubinemia requiring phototherapy during the nursery stay
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 |
|---|---|---|
| Home Nurse VisitHome nurse visit by maternal child health nurse within first 24-48 after post-partum hospital discharge. | Behavioural | – |
Primary outcome
Use of unplanned maternal and child healthcare services (inpatient, Emergency Department (ED), urgent/acute care, primary care, and mental health) in the first 14 days after delivery
Time frame: 3 years
6 secondary outcomes
Adherence to continuity of care guidelines
Time frame: 3 years
Postpartum anxiety
Time frame: 3 years
Breastfeeding duration
Time frame: 3 years
Maternal satisfaction with post-discharge healthcare
Time frame: 3.5 years
Parenting sense of competence
Time frame: 3.5 years
Cost of care
Time frame: 4 years
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 28 Jul 2017.
- Derived from this study: PubMed 25549051Hackman NM, Schaefer EW, Beiler JS, Rose CM, Paul IM. Breastfeeding outcome comparison by parity. Breastfeed Med. 2015 Apr;10(3):156-62. doi: 10.1089/bfm.2014.0119. Epub 2014 Dec 30.
- Derived from this study: PubMed 23460682Paul IM, Downs DS, Schaefer EW, Beiler JS, Weisman CS. Postpartum anxiety and maternal-infant health outcomes. Pediatrics. 2013 Apr;131(4):e1218-24. doi: 10.1542/peds.2012-2147. Epub 2013 Mar 4.
- Derived from this study: PubMed 23215909Bartok CJ, Schaefer EW, Beiler JS, Paul IM. Role of body mass index and gestational weight gain in breastfeeding outcomes. Breastfeed Med. 2012 Dec;7(6):448-56. doi: 10.1089/bfm.2011.0127. Epub 2012 Jun 25.
- Derived from this study: PubMed 22064874Paul IM, Beiler JS, Schaefer EW, Hollenbeak CS, Alleman N, Sturgis SA, Yu SM, Camacho FT, Weisman CS. A randomized trial of single home nursing visits vs office-based care after nursery/maternity discharge: the Nurses for Infants Through Teaching and Assessment After the Nursery (NITTANY) Study. Arch Pediatr Adolesc Med. 2012 Mar;166(3):263-70. doi: 10.1001/archpediatrics.2011.198. Epub 2011 Nov 7.
- Penn State Milton S. Hershey Children's Hospital Pediatric Clinical Research OfficeLink provided by the sponsor.
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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.
Ian M Paul, MD, MSc principal investigator
Penn State Milton S. Hershey Children's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Home Nurse Visit in people with Hyperbilirubinemia and Jaundice, run by Milton S. Hershey Medical Center at 2 sites in United States.
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 4 inclusion and 13 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 28 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Use of unplanned maternal and child healthcare services (inpatient, Emergency Department (ED), urgent/acute care, primary care, and mental health) in the first 14 days after delivery (time frame: 3 years). 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 NCT00360204, which also lists 4 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 28 Jul 2017.