Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT03585192 |
| Other study ID # |
09-17-24 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 8, 2017 |
| Est. completion date |
May 1, 2019 |
Study information
| Verified date |
May 2019 |
| Source |
University Hospitals Cleveland Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Late-preterm neonates are born between 34 and 36 weeks 7 days gestational age (GA). Neonates
born less than 34 weeks GA are at increased risk for morbidity and directly admitted to the
Neonatal Intensive Care Unit (NICU). Skin-to-skin contact (SSC) is a standard of care in many
units to aid in post-natal transitioning. Current guidelines published by the Neonatal
Resuscitation Program (NRP) and American Academy of Pediatrics (AAP) recommend only
"vigorous, term" neonates initiate immediate SSC. There is no published data regarding safety
or guidelines relating to late-preterm neonates and immediate SSC. Therefore, the
investigators hypothesize that post-natal transitioning after immediate SSC within the first
hours after birth will be no worse for vigorous, singleton 35 0/7 to 36 6/7 week neonates
compared to those who transition to SSC after an initial period of 20 minutes observation
under the radiant warmer.
Description:
Aim: Determine safety of immediate skin-to-skin in vigorous 35 0/7 to 36 6/7 week
late-preterm singleton neonates after vaginal delivery compared to current practice of
observation under the radiant warmer for 20 minutes.
Organization - University Hospital's Cleveland Medical Center Department of Obstetrics &
Gynecology and Rainbow Babies Children's Hospital Department of Neonatology will be the only
participating members.
Study Design - This is a prospective, randomized-control, and equivalence study. The cohort
of subjects that will be recruited for this study will include singleton neonates born via
vaginal delivery to Mothers at 35 0/7 to 36 6/7 weeks GA in UH MacDonald Women's Hospital
Labor & Delivery Hospital.
Recruitment Procedures
1. Recruitment will occur at UH MacDonald Women's Hospital
2. Mothers who meet the inclusion criteria will be tracked in the EMR at time of admission
to the Labor & Delivery Unit.
3. Informed consent will be obtained by members of the research team.
4. Consenting process will occur at the time of Mother's admission to the Labor & Delivery
Unit.
5. Consent will be obtained in Mother's room.
6. Mother will not be consented if sedated, under distress from laboring process, or
clinically unstable per Labor & Delivery Team.
7. A copy of the consent will be given to the Mother, a copy kept in a locked, secure
office for research collection purposes, and a copy will be scanned into the electronic
medical record (EMR).
Randomization
1. Index cards with skin or warmer written on them will be placed in opaque, sealed
envelopes.
2. The envelopes will be shuffled randomly and numbered 1-120. The envelopes will be kept
in chronological order. Extra envelopes containing index cards will be made if needed
using the same randomized process.
3. Envelopes will be stored in the Neonatal Treatment Room adjacent to Operation Room 1 on
the Labor & Delivery Unit.
4. After obtaining informed consent and if the Mother is agreeable to participate in this
study, a sealed envelope will be brought to the laboring room and opened prior to
delivery. No one in the delivery room will know what is written on the index card. The
envelope will be opened right before delivery.
5. Skin is the intervention group (Group 1) and warmer is the control group (Group 2)
6. Information about how the newborn transitioned after birth will be collected, regardless
if newborn is in the skin or warmer group. The information gathered will be analyzed to
determine if there are any differences in postnatal transitioning between the two groups
of newborns.
Study Methods Preparation prior to vaginal delivery (all late-preterm neonates)
1. Prepare Mother to receive newborn (bra removed & uncover breasts)
2. Place warm blanket on Mother's abdomen to receive neonate.
3. Pulse oximeter will be turned on and placed bedside to allow uninterrupted contact and
positioning between Mother and neonate. Screen is to be visible to Labor & Delivery RN
at all times.
Initiate immediate SSC after vaginal birth of vigorous late-preterm neonate - Group 1 (skin)
1. Newborn Nurse will assist Mother with initiating skin-to-skin contact
2. Place nude neonate supine on warm blanket on Mother's abdomen
3. Suction mouth and nose if necessary, dry, & remove wet blanket
4. Place pulse oximeter on right upper extremity, hat, diaper, and cover with warm
receiving blanket
5. Assign 1 minute APGAR
6. Any change in clinical status of either Mother (based on clinical judgment by OB
Physician or Midwife) or neonate (based on clinical judgment by Pediatric Team or
Neonate's RN) will preclude continued SSC and warrant immediate intervention until
stabilized.
1. Interventions to stabilize neonate: repositioning on Mother's chest, ensure
unobstructed airway, oral suctioning with bulb syringe if needed, reapply pulse
oximeter, & remove from Mother's chest if needed.
Monitoring during postnatal transitioning
1. Place neonate in prone position on Mother's bare chest between breasts in upright
position within 5 minutes of birth
2. Monitor neonate's head position and ensure nose is unobstructed
3. Cover with 2-4 layers of warm receiving blankets
4. Assign 5 minute APGAR
5. Neonate to stay on Mother's chest for uninterrupted SSC for first 60-90 minutes of life
or until completion of first feed
6. Routine vital signs, including pulse oximetry, will be monitored and documented in the
EMR until Mother/neonate stable for transfer to antepartum unit. Vital signs will be
obtained per current UH protocol. Normal values and assessment data include:
1. Axillary temperature 36.5-37.5 degrees Celsius
2. Heart rate of 100 to 180 beats per minute (if not eating or crying)
3. Regular cardiac rhythm
4. Respiratory rate of 40-60 breaths per minute
5. Pulse oximetry parameters per NRP guidelines.
6. Any pulse oximetry reading < 88% at 1 hour of life will require the baby to be
repositioned on Mother's chest, ensure unobstructed airway, oral suctioning with
bulb syringe if needed, reapply pulse oximeter, & remove from Mother's chest if
needed.
7. Screening and management of postnatal glucose homeostasis will be instituted, as is
the current policy at UH MacHouse Women's Hospital, for all late-preterm neonates
until 24 hours of life.
7. Signs of tolerance of postnatal SSC:
1. Pink or with mild acrocyanosis
2. Respiratory effort easy, no audible grunting, or visible intercostal retractions
3. Alert, demonstrating feeding cues, or sleeping comfortably
4. Well-flexed posture with good tone
8. Any change in clinical status of either Mother (based on clinical judgment by OB
Physician or Midwife) or neonate (based on clinical judgment by Pediatric Team or
Neonate's RN) will preclude continued SSC and warrant immediate intervention until
stabilized.
1. Interventions to stabilize neonate: repositioning on Mother's chest, ensure
unobstructed airway, oral suctioning with bulb syringe if needed, reapply pulse
oximeter, & remove from Mother's chest if needed.
Monitoring of late-preterm neonate if randomized to Group 2 (warmer)
1. Initial period of observation (20 minutes) under the radiant warmer per current UH
protocol
2. Place pulse oximeter on right upper extremity
3. SSC within 1 hour after birth for at least 1 hour and until first breastfeed attempt
4. SSC protocol to be followed as detailed in (numbers 2-7)
5. Any change in clinical status of either Mother (based on clinical judgment by OB
Physician or Midwife) or neonate (based on clinical judgment by Pediatric Team or
Neonate's RN) will preclude continued SSC and warrant immediate intervention until
stabilized.
1. Interventions to stabilize neonate: repositioning on Mother's chest, ensure
unobstructed airway, oral suctioning with bulb syringe if needed, reapply pulse
oximeter, & remove from Mother's chest if needed.
Data Collection & Storage
1. Data to be de-identified once collected from the current electronic medical record and
entered into a linking log in a secure file in the RedCap Database.
2. Mother and Baby will be assigned a study number.
3. If randomized into Group 1 (skin), dyad will be identified as: Mother - MS1 and Baby -
S1. Each additional dyad randomized into Group 1 will continue sequentially (i.e. MS2,
MS3, & S2, S3, etc.)
4. Group 2 (warmer) will be identified as: Mother - MW1 and Baby - W1. Each additional dyad
randomized into Group 2 will continue sequentially (i.e. MW2, MW3, & W2, W3, etc.)
5. A separate, secure file in RedCap Database will be created for Mother's and baby's
information.
6. Maternal information to be collected: medical record number, age, race, gravida/para
status, prenatal screens, medical history, medications, date of delivery, time of
delivery, & planned feeding method (breast or formula).
7. Neonate information to be collected: medical record number, gestational age, sex, race,
Apgar scores (1, 5, & 10 minutes), time of initial SSC, & if SSC is interrupted (time &
reason). Vitals, including pulse oximetry, will be collected per UH protocol. If
respiratory distress is present, initial glucose level & time, time of initial feed, and
time of transfer & location (postpartum unit or NICU with admission diagnosis).
8. All of the above information will be collected throughout the entire hospital admission.
9. The investigators will also track any NICU admission and document reason for admission.
10. A data safety monitoring committee will periodically review the collected data to ensure
continued safety during ongoing trial.
Statistical Analysis & Power Calculations
The investigators will test the hypothesis that Apgar scores at 1, 5 and 10 minutes,
temperature at each measured time, presence of respiratory distress and oxygen saturation is
not worse among the SSC babies compared to those with the standard of care (warmer).
Means and standard deviations will be calculated for continuous variables, median and ranges
for scores, and counts and percentages for categorical variables. Differences between babies
in the two randomization groups will be analyzed using a t-test (for continuous variables,
such as temperature), a wilcoxon rank sum test (for ordinal variables, such as Apgar scores)
or chi-square test for categorical variables (such as presence of respiratory distress).
Prior to analysis, data will be tested for consistency with test assumptions and alternatives
(such as Fisher's exact instead of chi-square) will be used if more appropriate. P-values
will be one sided and a p<0.05 will be used to reject our hypothesis of non-inferiority.
Additional variables, such as characteristics of the Mother, can be analyzed in a similar
fashion for exploratory analyses or hypothesis generation for future studies, and this is not
the primary aim of this study. Randomization is implemented to minimize the need for
multivariate analyses.
In order to test a two sample non-inferiority hypothesis, a sample size of at least 46 in
each arm will result in at least 80% power to conclude no more than 4% worse in SCC group vs.
standard of care group (for continuous variables). Other test are only slightly less powered.
Therefore, the investigators aim to enroll at least 46 patients in each arm.
