Download Date : Sep 2013 COMMAND HOSPITAL (AIR FORCE)

“A STUDY OF FACTORS AFFECTING NEWBORN WEIGHT LOSS IN INITIAL 72
HOURS OF LIFE”
SYNOPSIS FOR REGISTRATION OF SUBJECT FOR DISSERTATION
TO
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE,
KARNATAKA.
IN PARTIAL FULFILLMENT OF REGULATIONS
FOR THE AWARD OF
MASTERS DEGREE IN PAEDIATRICS
IN RESPECT OF
Dr. RAVI JOSHI
PG. TRAINEE M.D (PEDIATRICS), DEPARTMENT OF PEDIATRICS,
COMMAND HOSPITAL (AF), BANGLORE-07.
GUIDE
WG CDR S K PATNAIK
ASSOCIATE PROFESSOR, DEPARTMENT OF PAEDIATRICS, COMMAND
HOSPITAL (AF), BANGLORE-560 007
1
Annexure-A
1.Name of candidate
: Dr. RAVI JOSHI
2. Name of Institution
:Command Hospital (Air Force),
Bangalore
3. Course of study and subject
:M.D. (PAEDIATRICS)
4. Date of admission
:July 2013
5. Title Of Topic
6. Brief resume of intended work
Need for the study
Review of Literature
Objectives of Study
7. Material and Methods
Source of data
Method of collection of data
: A STUDY OF FACTORS AFFECTING
NEWBORN WEIGHT LOSS IN INITIAL
72 HOURS OF LIFE
: APPENDIX ‘A’
: APPENDIX ‘B’
: APPENDIX ‘C’
: APPENDIX 'D'
8. Does the study require any investigation
and interventions to be conducted
on patients or other animals?
Has ethical clearance been obtained
from your institution?
: YES/NO
9 . Patient Performa
: APPENDIX ‘E’
10. Statistical Analysis
: APPENDIX ’F’
11. List Of References
: APPENDIX ‘G’
12. Patient Consent Form
: APPENDIX ‘H’
: YES/NO
2
14. Signature Of Candidate
15. Remarks of guide
A novel study with important implications in
clinical practice. There are scanty Indian studies on
this issue.
16. Name and designations of Guide
WG CDR S K PATNAIK
ASSOCIATE PROFESSOR,
DEPARTMENT OF PEDIATRICS,
COMMAND HOSPITAL (AF),
BANGLORE-560 007
Signature
17. Head of the Department
GP CAPT V.VENKATESHWAR
PROFESSOR AND HEAD
DEPARTMENT OF PEDIATRICS,
COMMAND HOSPITAL (AF),
BANGLORE-560 007
Signature
3
APPENDIX-A
6. BRIEF RESUME OF THE INTENDED WORK:
A study to determine the pattern of neonatal weight loss in initial 72 hrs of life and also the effects of
various factors like , urine/stool output ,maternal intravenous fluids in the preceding 2 hours prior to
labor and breast feeding frequency & adequacy.
Need for the study:
Newborn weight measurements are used as a key indicator of breastfeeding adequacy1. The purpose of
this study is to explore feeding & non-feeding factors that might be related to newborn output (urine &
stools) and weight loss and also to analyze how maternal fluids in labor or before a caesarean section are
related to newborn weight loss during the first three days following birth. Neonates receive only small
amounts of fluids in the first days following birth and they tend to lose weight in the first week before
they begin to gain weight. Excessive weight loss or inadequate weight gain can be indications of low
milk production or of suboptimal breast feeding2 or disease conditions which require immediate
attention. To ensure adequate intake and at the same time to avoid inappropriate supplementation,
parents and professionals need evidence to assess patterns of neonatal weight change and to make
decisions about infant feeding1. The range of weight loss can be influenced by a variety of factors.
However, minimal research has been done in this area to explore the impact of various factors on weight
loss including potential influence of maternal intravenous (IV) fluids received during labor1 .Few if any
studies have examined weight loss among newborns in India by weighing infants 12 hourly for the first
72 hrs of life. The initial published data regarding relationship between above factors is sparse & there
are conflicting opinions about what constitutes a normal neonatal weight loss and about when
interventions such as supplemental feedings should be considered.
4
APPENDIX B
REVIEW OF LITERATURE
Newborns are typically weighed within a few minutes following birth and that measurement becomes
the baseline for monitoring newborn weight loss. Newborn weight measurements are used as a key
indicator of breastfeeding adequacy. Clinicians debate the limits of acceptable neonatal weight loss in
the first 3 days.Current clinical practice guidelines recommend interventions, including extra
assessments or supplementation with formula, when weight loss exceeds 7% 1.Some authors identify a
loss of ≥10% as a sign of breastfeeding inadequacy2.Weight loss, in this case, is the percentage of
weight lost from the first weight measured (i.e., birth weight).With birth weight as baseline, newborns
may have an artificially high reference point for weight loss. Birth weight as a baseline against which to
assess weight loss is a universal choice, but it lacks sufficient empirical evidence1. According to
literature there are positive correlations noted between maternal IV fluids received before delivery and
breast feeding with neonatal output and newborn weight loss1. After excluding medications during
delivery and anesthesia, IV fluid is the one of the most significant factors associated with maximum
weight loss 2. In another study neonates experienced varying degrees of diuresis in the first 24 hours,
and the consequent weight loss appeared to be a correction. Newborns regained baseline weight by Day
7 and up to 98% returned to their baseline weight by Day 12 1.According to a study published in
International breast feeding journal it was found that the neonates experienced diuresis in the first 24
hours as evidenced by the positive correlation between maternal I.V fluids administered & neonatal
weight loss1.Many studies have shown that newborn weight loss is influenced by various factors like ,
primiparous mother, cesarean section , feeding method 3, delayed onset of lactogenesis, breastfeeding
with supplements 4, labor > 14 hours and multiparous women who receive labor pain medication and
maternal breast variations5. Infants receiving supplements will have significantly less weight loss when
compared to those exclusively breastfed6.
5
APPENDIX C
AIMS AND OBJECTIVES OF THE STUDY
AIM- To study the factors affecting newborn weight loss in initial 72 hours of life
OBJECTIVES1. Primary Objective
To assess the pattern of newborn weight loss in initial 72 hours after birth and the factors affecting it
2. Secondary Objectives
To assess the impact of initial weight loss on outcome at 10-12 days of life
6
APPENDIX-D
7. MATERIALS AND METHODS
STUDY DESIGN
Prospective Observational study
STUDY AREA
All Term Babies born in Command Hospital Air Force Bangalore from Dec 2013 to Dec 2014 , who
are on exclusive breast feeding.
Inclusion criteria:
All Term Babies born in Command Hospital Air Force Bangalore from Dec 2013 to Dec 2014, who are
on exclusive breast feeding.
Exclusion criteria :
1. Babies who receive I.V Fluids .
2. Babies discharged before 72 hrs of life (Cannot be followed up )
3. Babies who does not receive enteral feeds continuously for 72 hrs
4. Babies who required resuscitation at birth (apart from routine care ) ,asphaxiated
,diagnosed to have
septicemia ,Respiratory distress syndrome Hyperbilirubinemia requiring phototherapy or any other
condition which alters the physiological status & requires treatment at NICU/Special set ups
(Warmer/Phototherapy).
5. Babies born with significant congenital anomalies
6. Any other condition where urine output/weight of baby cannot be measured accurately.
STUDY PERIOD- December 2013 -December 2014.
STUDY POPULATION - All Term Babies born in Command Hospital Air Force Bangalore
from 2013 to 2014 who are on exclusive breast feeding (Exclusion criteria mentioned above )
SAMPLE SIZE - 200 mothers & their babies
7
CRITERIA FOR SAMPLE SELECTION
Inclusion criteria:
All Term Babies born in Command Hospital Air Force Bangalore from
2013 to 2014 who are on exclusive breast feeding.
Exclusion criteria –Mentioned above.
DRUG USED- Nil
METHOD OF COLLECTION OF DATAA. I.V Fluids received by mother 2 hrs before birth of the baby will be noted in mililitres .Also
mentioning ante natal risk factors if any.
B. Birth weight of newborn immediately after birth will be measured in grams.
C. Noting down the time of start of breast feeding, frequency, adequacy of breast feeding.
D. Noting down the time of passage of urine for first time
E. Measuring frequency & quantity of urine /stool output in newborns by weighing nappies once
in 12 hrs for 72 hrs.
F. Measuring weight of newborns every 12 hrs for 72 hrs.
G. Assessing the neonate for feeding pattern and weight at 10-12 days and any other significant
issues
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APPENDIX E
PATIENT PROFORMA
DATA RECORD FORM: Maternal data ,neonatal Output & weight loss in 1st 72 hours and markers of
dysfunctions
Study Case: Neo/ ……
NBB Son/daug of Service No………………Rank………. Name: ………………Unit ……… Contact
Tel No:………………
Maternal Name :………………..Age:…………….. Wt……………….. Ht………………..
LMP: …/…/2012. EDD:…/…/2012….
neonatal period
G…P…L…A…….Any morbidity in previous child in
Maternal Antibiotics: Aminoglycoside (gentamicin/amikacin)/cefotaxime/augmentin/……………….
NSAIDs other than acetaminophen: N/Y………………..
Morphine/…..
Sedation: Inj Tramadol/Inj
Mother’s medical history:
DM/PIH/IHCP/Hypothyroid/SLE/Connective/Anemia/febrile illness in 48 hrs prior/RHD/cardiac
disorder/……..
Any other situation leading to maternal hemodynamic instability prior to
delivery?..........................................
Twin/Multiple gestation
Any anomalies on USG :
Placental insufficiency: Last Grade of Placenta: ……date:……………….
Risk factor Summary :
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Prematurity/BOH/APH/PIH/DM/GDM/Maternal infection
Maternal creatinine: ……………. mg/dl
protein:ND/…..
BSL: …….. mg/dl
Urine
Labor data: I.V Fluids /Drugs given during delivery- Type /Duration of administration
Mode of delivery: SVD/LSCS- elective/LSCS-emergency/Vacuum/Forceps
Indication for Emergency LSCS/instrument: fetal distress/APH/failed induction/MSL/Prolonged
PROM/severe PIH/…..….
TOB: ……hrs DOB: …/…/2013
APGAR: 1’…. 5’…… Length:…………………
Urine passed in resuscitation trolley: Y/N
Urine sample taken: Y/N
Date of 1st Assessment :……./……/2013 Bwt:……… Length:……… OFC:…….
CANSCORE………………………….
Postdelivery care
Enteral feeding (breastmilk/formula) initiation time after birth:
10
Time
0 -12
hours
12-24 hours 24-36 hrs
36-48 hrs
48-60 hrs
60-72 hrs
12 hrs
12-24 hrs
24-36 hrs
36-48 hrs
48-60 hrs
60-72 hrs
Outcomes:
Breastfeeding and discharged:
Breastfeeding and needed topups during hospitalisaion and discharged
Readmitted with feeding issues: N/Y if Y specify
details………………………………………………………………………….
Signature of
Investigator:………………………………………………………………………………………………..
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INFORMATION TO PARTICIPANTS AND CONSENT FORM
You are invited to take part in this research study. The information in this document is meant to help
you decide whether or not to take part. Please feel free to ask if you have any queries or concerns.
You are being asked to participate in this study being conducted in CHAFB (name of the institution)
because you satisfy our eligibility criteria which is:
Term Babies born in Command Hospital Air Force Bangalore from Dec 2013 to Dec 2014, who
are exclusively on breast feeding.
1. Investigator –Dr Ravi Joshi ,PG Resident Dept Of Pediatrics,Guide Wg Cdr S K Patnaik
Associate Professor, Department Of Pediatrics, Command Hospital (AF), Banglore-560 007
2 Title: A STUDY OF FACTORS AFFECTING NEWBORN WEIGHT LOSS IN INITIAL 72
HOURS OF LIFE.
3.What is the nature and purpose of research?
Newborn weight measurements are used as a key indicator of breastfeeding adequacy. The purpose of
this study is to explore feeding & non-feeding factors that might be related to newborn output (urine &
stools) and weight loss.
You will be advised to use nappies , weight of the nappies & weight of your baby will be measured 12
hourly for 72 hours after birth.. These measurements will reveal whether you are feeding the baby
adequately or not ,any associated factor affecting eight loss in your baby and also it may detect any
abnormal weight loss pattern .
4. Duration of participation with number of participants
Each newborn enrolled into the study will need to be followed up for at least 72 hours after birth & once
after 12 days. Number of participants will be at least 200 children in total.
5. Procedures to be followed
Recruitment: All term babies born at this hospital who are on exclusive breast feeding
Follow-up: 72 hours after birth & once after 12 days.
Termination: Outcomes will be analyzed at end of 1 year to formulate the pattern of weight loss in
newborn babies in initial 72 hours.
6. Investigations, if any, to be performed -Nil
7. Foreseeable risks and discomforts and whether the project involves more than minimal
discomfort:
12
Risks involved are minimal and are limited to nappy rashes /frequent handling of babies , these will not
pose any problem to your baby.
8.Possible benefits to you.
You can come to know whether you are feeding your baby adequately or not,any associated factor
affecting weight loss in your baby and also it may detect any abnormal weight loss pattern which
requires further interventions.
9. Policy on compensation
Participation is purely voluntary and no extra payment will be given. Any untoward injury is not
anticipated during participation the project.
10. Availability of medical treatment for such injuries or risk management: Yes
11. Steps taken to ensure confidentiality:
All data pertaining to your baby will be coded and will be known only to the investigators after end of
study. No data sharing is permitted.
12. No loss of benefits on withdrawal :
Your decision not to participate in this research study will not affect your medical care or your
relationship with the investigator or the institution. Your doctor will still take care of you and
you will not lose any benefits to which you are entitled.
13. Contact details of PI for asking more information related to research or in case of injury.
Dr Ravi Joshi ,PG Resident Dept Of Pediatrics .Mobile number -9916752767 ,Email ID –
[email protected]
14. Contact details of Chairman of the IEC for appeal against violation of rights
Chairman, IEC, Command Hospital (AF), Bangalore 560007
Participant’s initials: ____
13
PATIENT CONSENT FORM
Name of the participant: ____________________________________________
Name of the Principal (Co-) Investigator: ______________________________
Name of the Institution: ____________________________________________
Documentation of the informed consent
I, … … … … … … … … … ., have read the information in this form (or it has been read to me). I was
free to ask any questions and they have been answered.
(1) I have read and understood this consent form and the information provided to me.
(2) I have had the consent document explained to me.
(3) I have been explained about the nature of the study.
(4) My rights and responsibilities have been explained to me by the investigator.
(5) I have been advised about the risks associated with my participation in the study.
(6) I am aware of the fact that I can opt out of the study at any time without having to give any
reason and this will not affect my future treatment in the hospital.
(7) I am also aware that the investigators may terminate my participation in the study at any
time, for any reason, without my consent.
(8) I hereby give permission to the investigators to release the information obtained from me as
result of participation in this study to the sponsors, regulatory authorities, Government
agencies, and ethics committee. I understand that they may inspect my original records.
(9) My identity will be kept confidential if my data are publicly presented.
(10) If, despite following the instructions, I am physically harmed because of any substance or
any procedure as stipulated in the study plan, [my treatment will be carried out free at the
investigational site / the sponsor will bear all the expenses], if they are not covered by my
insurance agency or by a Government program or any third party.
(11) I have had my questions answered to my satisfaction.
(12) I have decided to be in the research study.
I am aware, that if I have any questions during this study, I should contact at one of the
addresses listed above. By signing this consent from, I attest that the information given in this
document I will be given a copy of this consent document.
Participant’s initials: ____
Investigator Certificate
14
I certify that all the elements including the nature, purpose and possible risks of the
above study as described in this consent document have been fully explained to the subject. In
my judgment, the participant possesses the legal capacity to give informed consent to participate
in this research and is voluntarily and knowingly giving informed consent to participate,
Signature of the Investigator: ________________ Dated:__________
Name of the Investigator: __________________
APPENDIX - F
Statistical Analysis
Statistical analysis shall be done by appropriate statistical methods.
15
APPENDIX-G
LIST OF REFERENCES`
.
I.
Joy Noel Weiss, A.Kirsten Woodend, Wendy.E.Peterson, William Gibb and Dianne L Groll ,
Noel-Weiss et al., International Breastfeeding Journal 2011, :9 doi:10.1186/1746-4358-6-9 -
II.
Dewey KG, Nommsen-Rivers LA, Heinig MJ, Cohen RJ: Risk factors for suboptimal infant
breastfeeding behavior, delayed onset of lactation,and excess neonatal weight loss. Pediatrics
2003; 112:607-619.
III.
Martens, P., & Romphf, L. Factors associated with newborn in-hospital weight loss:
Comparisons by feeding method, demographics, and birthing procedures. Journal of Human
Lactation, (2007). 23(3), 233-241.
IV.
Chantry, C., Nommsen-Rivers, L., Peerson, J., Cohen, R., & Dewey, K. Excess weight loss in
first-born breastfed newborns relates to maternal intrapartum fluid balance. Pediatrics, (2011).
127(1), e171-e179.
V.
Vazirinejad, R., Darakhshan, S., Esmaeili, A., & Hadadian, S. The effect of maternal breast
variations on neonatal weight gain in the first seven days of life. International Breastfeeding
Journal, . (2009) 4:13.
VI.
Robin Hirth, BS, M.Ed, IBCLC, RLC, Tina Weitkamp, Alok Dwivedi, Ph.D., MSc, BSc
Infant weight loss, maternal IV fluids, labor Clinical Lactation, 2012, Vol. 3-2, 59-63
16
CERTIFICATE OF ACCEPTANCE BY THE GUIDE
I, Wg Cdr S K Patnaik, Associate Professor, Department Of Pediatrics, Command
Hospital (AF), Banglore-560 007 , hereby certify that I accept Dr Ravi Joshi as a
candidate for MD (Pediatrics). The title of the dissertation is as followsA STUDY OF FACTORS AFFECTING NEWBORN WEIGHT LOSS IN INITIAL
72 HOURS OF LIFE.
He will be under my guidance during the entire period of his study and thesis work.
WG CDR S K PATNAIK
ASSOCIATE PROFESSOR
DEPARTMENT OF
PEDIATRICS,
COMMAND HOSPITAL (AF),
BANGLORE-560 007
17
CERTIFICATE FROM ETHICAL COMMITTEE
The committee has examined the scope including the aim, objectives, method of data collection &
human/animal intervention of the following study to be carried out by accept Dr Ravi Joshi under
the guidance of WG CDR S K PATNAIK , title of which is
A STUDY OF FACTORS AFFECTING NEWBORN WEIGHT LOSS IN INITIAL 72 HOURS OF
LIFE
The committee has no objection for undertaking this study at
Command Hospital (Air force), Bangalore, 560007.
Salini Chaudhary) (S Kaistha)
(SK Jha)
Sq Leader
Wg Cdr
Col
OIC Legal Cell
Rep of AFWWA OIC
Member
Member
PG Cell
Member
(SC Dash)
Col
Prof & HOD
Surgery
Member
(Mrs. Vasantha kishore)
Counsellor
(Dr V Sinha)
Scientist ‘D’ Physiologist
E- support
Member
(MS Parkash)
Brig
Prof & HOD
Medicine
Secretary
Member
(MK Bedi)
Air Cmde
AOC MTC
Chairman Ethical Committee
Command Hospital (Air Force)
Bangalore – 560007
18
(H Sahni)
Gp Capt
OIC AFMRC
Member
CERTIFICATE FROM THE HEAD OF THE INSTITUTION
Permission is hereby accorded to the student Dr Ravi Joshi , to undergo MD (Pediatrics) course
being conducted at Command Hospital (Air Force) Bangalore , affiliated to Rajiv Gandhi
University of Health Sciences Karnataka, Bangalore commencing from July 2013 under the
guidance WG CDR S K PATNAIK , Associate Professor, and Command Hospital (Air Force)
Bangalore- 560007
Place : CHAFB
COMMANDANT AND PRINCIPAL
Date :
COMMAND HOSPITAL (AIR FORCE)
Sep 2013
BANGALORE- 560007
19